Kidney Cancer

EA8211 / SOAR



Focused Radiation versus Systemic Therapy for Kidney Cancer Patients with Limited Metastasis, SOAR Trial

STATUS: Active


This phase III trial compares the effect of stereotactic ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with renal cell carcinoma or RCC (the most common type of kidney cancer) that has spread from where it first started (primary site) to a limited number of places in the body (metastatic). There are patients with metastatic RCC who have limited metastatic disease (oligometastatic). In patients with advanced oligometastatic disease, radiation therapy as a local treatment of metastatic lesions may be beneficial (without systemic therapy and associated toxicity and costs). Previous small-scale studies have demonstrated that SAbR alone can control oligometastatic RCC for some time, which may be comparable to the control afforded by systemic therapies. However, to confirm this finding, larger scale studies like this must be performed to check whether SAbR can become a standard option for such patients in the future. Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors. SAbR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. SAbR may allow patients to live longer with better quality of life. SAbR may delay or possibly eliminate the need for systemic therapy and its more serious side effects. Giving SAbR prior to systemic therapy may kill the tumor cells more efficiently than the usual approach with systemic therapy alone.
  • Patient must be >= 18 years of age

  • Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization

  • Patient may have any RCC histology except a histology that has a sarcomatoid component

  • Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization

  • Patient must not have brain metastases

  • Patient must have favorable or intermediate International Metastatic RCC Database Consortium (IMDC) risk (0-2) at the time of randomization

  • Patient must have a total of between 2 and 5 metastatic lesions, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria with imaging obtained within 45 days prior to randomization

  • Patient must have a documentation from a radiation oncologist confirming that all sites are amenable to SAbR

  • Patient may have received prior therapy in the adjuvant setting as long as potential trial participants have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment

  • Patient must not have metastasis involving the following locations: ultra-central (within 2cm of carina) lung, invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum), skin, and scalp

  • Patient must not have received any prior systemic therapy (except for adjuvant setting) for metastatic RCC

  • Patient must not have severe, active comorbidity defined as any of the following: * Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies * Active tuberculosis (purified protein derivative [PPD] response without active tuberculosis [TB] is allowed) * Uncontrolled hypertension (systolic blood pressure [BP] > 190mmHg or diastolic BP > 110mmHg) * Major surgery within 30 days prior to randomization * Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization * Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-STEMI [NSTEMI], cerebrovascular accident [CVA], etc.) events within 180 days prior to randomization * Moderate or severe hepatic impairment (child-Pugh B or C) * Untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed. Treated PE or DVT is allowed > 30 days from diagnosis and when not resulting in respiratory impairment * Unstable cardiac arrhythmia within 180 days prior to randomization * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to randomization * History of or active inflammatory bowel disease * Malabsorption syndrome within 30 days prior to randomization

  • 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 trial

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used

  • All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy * 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: ** Has achieved menarche at some point ** Has not undergone a hysterectomy or bilateral oophorectomy ** 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)

  • Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. 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

  • Patient must have a Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

  • Patients must have adequate organ and bone marrow function as per the recommended guidelines and the respective Food and Drug Administration [FDA] package insert required for the systemic therapy chosen by the treating oncologist. We recognize that patients may have varying levels of renal and liver function that will impact which systemic therapy is appropriate for the patient. We do not require all patients to have specific baseline laboratory thresholds but do ask the treating oncologist to attest that the patient has adequate organ and bone marrow function to safely receive one of the first line systemic therapies listed in the protocol as a standard of care treatment option

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study

  • For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry onto the study

  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study

  • In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish * NOTE: Sites cannot translate the associated QOL forms

United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu

CO
Aurora
UCHealth University of Colorado Hospital
Contact: Site Public Contact

Fort Collins
Cancer Care and Hematology-Fort Collins
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
Contact: Site Public Contact

Greeley
UCHealth Greeley Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Highlands Ranch
UCHealth Highlands Ranch Hospital
Contact: Site Public Contact

Loveland
Medical Center of the Rockies
Contact: Site Public Contact

IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact

McFarland Clinic - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Ankeny
Mission Cancer and Blood - Ankeny
Contact: Site Public Contact

Cedar Rapids
Mercy Hospital
Contact: Site Public Contact

Oncology Associates at Mercy Medical Center
Contact: Site Public Contact

Clive
Mission Cancer and Blood - West Des Moines
Contact: Site Public Contact

Des Moines
Iowa Methodist Medical Center
Contact: Site Public Contact

Mission Cancer and Blood - Des Moines
Contact: Site Public Contact

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

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

OSF Saint Joseph Medical Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

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

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

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

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

University of Illinois
Contact: Site Public Contact

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

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

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

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

KS
Fairway
University of Kansas Clinical Research Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Olathe
Olathe Health Cancer Center
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org

Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Salina
Salina Regional Health Center
Contact: Site Public Contact
Email: mleepers@srhc.com

Topeka
University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact

Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

KY
Louisville
The James Graham Brown Cancer Center at University of Louisville
Contact: Site Public Contact

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

Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Chelsea
Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Lansing
University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact
Email: harsha.trivedi@umhsparrow.org

Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

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

Kansas City
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Springfield
Mercy Hospital Springfield
Contact: Site Public Contact

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

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

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

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact

New York
Lenox Hill Hospital
Contact: Site Public Contact

Manhattan Eye Ear and Throat Hospital
Contact: Site Public Contact

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

PA
Philadelphia
ECOG-ACRIN Cancer Research Group
Contact: Raquibul Hannan
Email: raquibul.hannan@utsouthwestern.edu

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

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

TX
Dallas
UT Southwestern Simmons Cancer Center - RedBird
Contact: Site Public Contact
Email: canceranswerline@utsouthwestern.edu

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

Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

VA
Richmond
VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact
Email: ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu

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

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

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

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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

PRIMARY OBJECTIVES:
I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy (SABR+ST) versus systemic therapy (ST) only.
II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm.

SECONDARY OBJECTIVES:
I. To compare global health status / quality of life (QOL) between patients receiving SAbR+ST versus ST only. 
II. To compare progression-free survival (PFS) between the arms.

EXPLORATORY OBJECTIVES:
I. To estimate PFS on first line systemic therapy (PFS-SST) in the SAbR+ST arm and compare with first line systemic therapy PFS of the ST arm.
II. To explore local control from SAbR by looking at the amount of local failures after SAbR in the SAbR+ST arm.
III. To assess the cost-effectiveness between the arms in terms of cost per unit gain in quality-of-life years.

QUALITY OF LIFE (QOL) OBJECTIVES:
I. To compare global health status / quality of life (QOL) between patients receiving SabR+ST versus ST only using the National Comprehensive Cancer Network (NCCN) / Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index -19 item (NFKSI-19).
II. To compare quality-adjusted survival between patients randomized to receive SabR+ST versus ST alone using European Quality of Life (EUROQOL) 5-dimension, 5-level (EQ-5D-5L) at 3, 6, 9, 12, 18, and 24 months.
III. To compare global health status / QOL of the NFKSI-19 at all of the 3, 6, 9, 12, 18, and 24 month time points between patients randomized to receive SabR+ST versus ST alone.
IV. To compare scale scores of the NFKSI-19 (disease-related symptoms - physical disease-related symptoms - emotional, treatment side effects, and function & well-being) at 3, 6, 9, 12, 18, 24 months between patients randomized to receive SabR+ST versus ST alone.
V. To compare time to global quality of life deterioration between patients randomized to receive SabR+ST versus ST alone using NFKSI-19.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care systemic therapy at the discretion of the treating provider on study.

ARM II: Patients undergo sequential SAbR until progression and then receive standard of care systemic therapy at the discretion of the treating provider on study.

Patients in both arms undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial.

After completion of study intervention, patients are followed up every 3 months for years 1 and 2, every 6 months for years 2-5, and then every 12 months for years 5-10 from the date of randomization.

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.


EA8211 / SOAR Home Page
ECOG-ACRIN Cancer Research Group