Esophagus and Stomach Cancer

EA2183



Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients with Esophageal and Gastric Cancer that has Spread to a Limited Number of Other Places in the Body

STATUS: Active


This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
  • REGISTRATION TO STEP 1

  • Patient must be >= 18 years of age

  • Patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (American Joint Committee on Cancer [AJCC] 8th edition) with known PDL1 CPS expression

  • Patient must have oligometastatic disease at the time of diagnosis of metastatic disease and prior to initiation of induction systemic therapy, which is defined as the following: * Once to three (1-3) radiologically visible metastatic lesions (not sites), in addition to the primary site. Computed tomography (CT) or magnetic resonance imaging (MRI) scans will be performed for staging purposes. Patients with oligometastatic sites that are only detected with positron emission tomography (PET)/CT will be eligible for participation, as long as radiation planning and administration is feasible after discussion with treating radiation oncologist. Malignant lymph node must be at least 1 cm in size or biopsy proven involved by disease * Anatomically defined lymphadenopathy will be considered as 1 metastatic lesion. For example, 2 enlarged paraaortic lymph nodes will be considered as one lesion, and 2 additional lesions will be allowed to meet protocol definition of oligometastatic disease. However, if supraclavicular or cervical nodes are involved for distal esophageal tumors or gastric tumors, these are counted separately from intrathoracic nodes. For upper thoracic/cervical esophageal tumors, the involvement of celiac nodes are counted separately from intrathoracic nodes. Intrathoracic nodes, defined as hilar and mediastinal nodes, will be collectively counted as one * Patients with radiologically evident peritoneal metastasis are not eligible.

  • Patient must have baseline imaging done within 4 weeks prior to Step 1 registration. For patients registering to Arm S, scans must demonstrate at least stable disease after induction systemic therapy

  • Patient must not have any contraindications to 5-fluorouracil (5-FU) capecitabine, leucovorin, or oxaliplatin

  • Patients who receive(d) nivolumab in addition to chemotherapy must not have any contraindications to immune check point inhibitors * Patient must not have active autoimmune disease that has required systemic treatment within 2 years prior to Step 1 registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to Step 1 registration. Inhaled or topical steroids and adrenal replacement doses (=< 10 mg/day prednisone equivalent) are permitted * Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible

  • Patient must not have any contraindications to radiation therapy based on consultation with a radiation oncologist. Formal radiation oncology evaluation will be required for eligibility purposes. Prior palliative or definitive radiation or chemoradiation to the primary site is allowed. Palliative treatments must be completed at least 2 weeks prior to registration

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Patient must not be pregnant or breast-feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * A patient of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to Step 1 registration * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception (both double barrier contraception and birth control pills or implants) or by abstaining from sexual intercourse while on protocol treatment (for all patients) and continue for 5 months after the last dose of protocol treatment (for patients of child bearing potential). Investigators must counsel all patients on the importance of pregnancy prevention and the implications of an unexpected pregnancy

  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained within 28 days prior to Step 1 registration)

  • Hemoglobin >= 8 g/dL (obtained within 28 days prior to Step 1 registration)

  • Platelets (PLT) >= 100 x 10^9/L (obtained within 28 days prior to Step 1 registration)

  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN) (obtained within 28 days prior to Step 1 registration)

  • Bilirubin =< 1.5 x institutional ULN (obtained within 28 days prior to Step 1 registration)

  • Serum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula) (obtained within 28 days prior to Step 1 registration)

  • Albumin > 2.5 g/dL (obtained within 28 days prior to Step 1 registration)

  • Patient must be able to understand and willing to sign and date the written voluntary informed consent form prior to any protocol-specific procedures. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this protocol and must have CD4 > 200 within 6 months prior to registration *NOTE: HIV testing is not required for eligibility

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this protocol

  • Patients who had prior definitive treatment for early stage EGA are eligible for participation as long as recurrent disease developed at least 6 months after completion of all prior therapies

  • For patients registering to Arms A, B, G, or H, patient must not have had any systemic prior treatment for metastatic disease * NOTE: Patients previously treated with radiosensitizing doses of 5-FU and oxaliplatin will be eligible for participation as long as adequate time has elapsed from past treatments. If treatments were palliative in nature, 2 week washout is required. For prior definitive treatments with curative intent, recurrent disease must be diagnosed at least 6 months after treatment completion * NOTE: Patients who received systemic chemotherapy as part of the treatment for their locoregional disease (for example, induction therapy before chemoradiation or adjuvant therapy after resection) are eligible for participation, as long as all definitive therapy has been completed at least 6 months prior to Step 1 registration

  • For patients registering to Arm S, patient must have completed at least 4 months, but not more than 5 months of systemic induction therapy for advanced disease (with CAPOX, FOLFOX, CAPOX plus nivolumab, or FOLFOX plus nivolumab)

  • Any major surgery must have been completed >= 4 weeks prior to Step 1 registration

  • Patients with known central nervous system (CNS) metastasis will be excluded from protocol participation, regardless of the status of the CNS disease

  • Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

  • Patient must not have had live vaccines within 4 weeks prior to Step 1 registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)

  • REGISTRATION TO STEP 2

  • For patients registered to Arms A, B, G or H on Step 1, the patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (AJCC 8th edition) with stable disease after 4 cycles of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) or 6 cycles of CAPOX (Step 1 treatment). For patients registered to Arm S on Step 1, patients must have completed at least 4 months, but not more than 5 months of systemic induction therapy for advanced disease (with CAPOX, FOLFOX, CAPOX plus nivolumab, or FOLFOX plus nivolumab)

  • Patient must have no evidence of disease progression since systemic induction treatment initiation (all patients on Arms A, B, G, H and S). Imaging must be done within 7 days prior to Step 2 randomization. Patients with complete radiologic response are eligible for Step 2

  • Patient must have an ECOG performance status 0-1

  • For patients registered to Arms A, B, G or H on Step 1 must have a serum or urine pregnancy test to rule of pregnancy within 14 days prior to Step 2 randomization

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact

AZ
Kingman
Kingman Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

CA
Arroyo Grande
PCR Oncology
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Salinas
Salinas Valley Memorial
Status: ACTIVE
Contact: Site Public Contact
Email: tnielsen2@svmh.com

FL
Fort Lauderdale
Holy Cross Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

IA
Carroll
Saint Anthony Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sbenson@iora.org

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact

Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact

Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact

Fort Dodge
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact

West Des Moines
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Status: ACTIVE
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@northwestern.edu

University of Illinois
Status: ACTIVE
Contact: Site Public Contact

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact

Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Homer Glen
Loyola Medicine Homer Glen
Status: ACTIVE
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact

Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

MA
Springfield
Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

ME
Bath
MaineHealth Coastal Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: ctsucontact@westat.com

Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: ACTIVE
Contact: Site Public Contact
Email: LLemire@mmc.org

Portland
Maine Medical Center-Bramhall Campus
Status: ACTIVE
Contact: Site Public Contact

Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: ACTIVE
Contact: Site Public Contact
Email: LLemire@mmc.org

MaineHealth Cancer Care Center of York County
Status: ACTIVE
Contact: Site Public Contact

Scarborough
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Email: wrighd@mmc.org

South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

MI
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bay City
McLaren Cancer Institute-Bay City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

McLaren Cancer Institute-Clarkston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Farmington Hills
Weisberg Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

McLaren Cancer Institute-Flint
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Singh and Arora Hematology Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Karmanos Cancer Institute at McLaren Greater Lansing
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mid-Michigan Physicians-Lansing
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact

Lapeer
McLaren Cancer Institute-Lapeer Region
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Livonia
Hope Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Mount Clemens
McLaren Cancer Institute-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Email: karen.fife@ascension.org

Petoskey
McLaren Cancer Institute-Northern Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Pontiac
21st Century Oncology-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Port Huron
McLaren-Port Huron
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Email: karen.fife@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Thief River Falls
Sanford Thief River Falls Medical Center
Status: ACTIVE
Contact: Site Public Contact

Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Worthington
Sanford Cancer Center Worthington
Status: ACTIVE
Contact: Site Public Contact

Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: amy.hanneman@providence.org

ND
Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact

Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact

NV
Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Shadow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OH
Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
First Dayton Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: ACTIVE
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bryn Mawr
Bryn Mawr Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Collegeville
Main Line Health Center-Collegeville
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

East Stroudsburg
Pocono Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Exton
Main Line Health Center-Exton
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Hazleton
Lehigh Valley Hospital-Hazleton
Status: ACTIVE
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Media
Riddle Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact

Wynnewood
Lankenau Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TN
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact

TX
Dallas
Parkland Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT
Farmington
Farmington Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

University of Utah Sugarhouse Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

WI
Antigo
Langlade Hospital and Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Juli.Alford@aspirus.org

Eau Claire
HSHS Sacred Heart Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Johnson Creek
UW Cancer Center Johnson Creek
Status: ACTIVE
Contact: Site Public Contact
Email: lynda.persico@uwmf.wisc.edu

La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wausau
Aspirus Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: ACTIVE
Contact: Site Public Contact

WY
Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. Overall survival (OS), which will be measured from the time of randomization.

SECONDARY OBJECTIVES:
I. Safety and tolerability of consolidative radiation therapy in the treatment of oligometastatic esophageal and gastric adenocarcinoma (EGA).
II. Progression-free survival (PFS) which will be measured from the time of randomization.

OUTLINE:

STEP 1 (INDUCTION PHASE): Patients are assigned to 1 of 5 arms. 

ARM A: Patients receive oxaliplatin intravenously (IV) over 1.5 hours, leucovorin IV over 1.5 hours, and 5-fluorouracil IV over 46-48 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM G: Patients receive treatment as in Arm A. Patients also receive nivolumab IV on day 1 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM H: Patients receive treatment as in Arm B. Patients also receive nivolumab IV on day one of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM S: Patients who completed induction therapy prior to study enrollment and have no evidence of disease progression are assigned to Arm S and may proceed directly to Step 2 randomization.

STEP 2 (CONSOLIDATION): Patients on Arms A or S are randomized to either Arms C or D. Patients on Arm B or S are randomized to either Arms E or F. Patients on Arms G or S are randomized to either Arms I or J. Patients on Arms H or S are randomized to Arms K or L.

ARM C: Patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.

ARM D: Patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.

ARM E: Patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients continue oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.

ARM F: Patients continue oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.

ARM I: Patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients continue oxaliplatin, leucovorin, 5-fluorouracil and nivolumab as outlined in Arm G for 2 years in the absence of disease progression or unacceptable toxicity.

ARM J: Patients continue oxaliplatin, leucovorin, 5-fluorouracil, and nivolumab as outlined in Arm G for 2 years in the absence of disease progression or unacceptable toxicity.

ARM K: Patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients continue oxaliplatin, capecitabine, and nivolumab as outlined in Arm H for 2 years in the absence of disease progression or unacceptable toxicity.

ARM L: Patients continue oxaliplatin, capecitabine, and nivolumab as outlined in Arm H for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 5 years from study entry. Patients experiencing disease progression are followed up every 3 months in years 1-2, and then every 6 months for up to 5 years from study entry.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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