Nose and Sinus Cancer

EA3163



Chemotherapy before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients with Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

STATUS: Active


This phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Chemotherapy drugs, such as docetaxel, cisplatin, and carboplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.
  • Patients must be >= 18 years of age

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Patients must have a general physical condition compatible with the proposed chemotherapy and surgery

  • Patients must have stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some patients with T4b disease deemed resectable by the treating surgeon can be included provided they fulfill all other eligibility criteria without involvement of the cavernous sinus

  • Patients with T4b who have the following characteristics leading to a T4b definition but who in the opinion of the treating surgeon can have resectable disease can be included provided they fulfill all other eligibility criteria and provided they have one of the following presentations: 1. Invasion of orbital apex without involvement of the cavernous sinus 2. Dura invasion depending on extent of involvement and if total resection is deemed feasible. 3. Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible. 4. Nasopharynx invasion if very limited 5. Clivus invasion if very limited. (Surgeons are encouraged to consult with the protocol surgical chair for these particular cases). Stages T3 and T4a and selected T4b disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection. The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neoadjuvant chemotherapy for patients on Arm B using the score sheet provided at the end of the protocol. * Resection of skull base will be deemed necessary according to skull base bone erosion by computed tomography (CT) or marrow involvement by magnetic resonance imaging (MRI) is noted; for any disease abutting the skull base * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging

  • Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization

  • Patients may not be receiving investigational agents at time of randomization, or at any time while on study and during the 4 weeks preceding randomization

  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and/or both platinum-based chemotherapy agents are ineligible; patient must be able to receive at least one of the two proposed chemotherapy regimens

  • Patients with evidence of distant metastases or leptomeningeal disease (LMD) are ineligbile

  • Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors

  • Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are ineligbile

  • Patients with a history of a different malignancy are ineligible, unless the disease has not progressed for >= 2 years

  • Absolute neutrophil count (ANC) > 1500/mm^3 (=< 2 weeks prior to randomization)

  • Hemoglobin (Hgb) > 8.0 g/dL (=< 2 weeks prior to randomization)

  • Platelet count > 100,000/mm^3 (=< 2 weeks prior to randomization)

  • For patients receiving cisplatin, creatinine clearance must be > 60 ml/min (=< 2 weeks prior to randomization); creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockcroft-Gault formula

  • Total bilirubin within 1.5 x the upper limit of normal (ULN) (must be obtained =< 2 weeks prior to randomization)

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)

  • Alkaline phosphatase must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)

  • Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated

  • Patient must not have current peripheral neuropathy > grade 2 at time of randomization

  • Patient must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

  • 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 chemotherapy and radiation being used; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy * All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achived menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patient must not be expected conceive or father children by using an accepted and effective method(s) of contraception or by abstain from sexual intercourse for the duration of their participation in the study

  • Patient must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to randomization

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

AZ
Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Site Public Contact
Email: UACC-NCTN@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Status: ACTIVE
Contact: Site Public Contact

University of Arizona Cancer Center-Orange Grove Campus
Status: ACTIVE
Contact: Site Public Contact

CA
La Jolla
UC San Diego Moores Cancer Center
Status: WITHDRAWN
Contact: Site Public Contact
Email: cancercto@ucsd.edu

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Email: ccto-office@stanford.edu

VA Palo Alto Health Care System
Status: ACTIVE
Contact: Site Public Contact

CT
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: ACTIVE
Contact: Site Public Contact

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center - McKinley Campus
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center-International Plaza
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

GA
Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Email: allyson.anderson@emory.edu

Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact

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

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

Iowa Lutheran Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

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

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

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

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

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

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

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

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

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

Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical_trials@rush.edu

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

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

Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: ACTIVE
Contact: Site Public Contact

Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: ACTIVE
Contact: Site Public Contact

Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

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

Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

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

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

Pittsburg
Ascension Via Christi - Pittsburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org

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

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

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

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

MA
Boston
Massachusetts General Hospital Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Dearborn
Henry Ford Medical Center-Fairlane
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

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

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

Jackson
Allegiance Health
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Novi
Henry Ford Medical Center-Columbus
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: tpearce1@hfhs.org

West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

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

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

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

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

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

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

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

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

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

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

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

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

Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact

MT
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

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

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

NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Middletown
Memorial Sloan Kettering Monmouth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Montvale
Memorial Sloan Kettering Bergen
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

NY
Bay Shore
Northwell Health Imbert Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Bronx
Montefiore Medical Center - Moses Campus
Status: ACTIVE
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: eskwak@montefiore.org

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

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

New Hyde Park
Long Island Jewish Medical Center
Status: ACTIVE
Contact: Site Public Contact

New York
Lenox Hill Hospital
Status: ACTIVE
Contact: Site Public Contact

Manhattan Eye Ear and Throat Hospital
Status: ACTIVE
Contact: Site Public Contact

Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mount Sinai Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: CCTO@mssm.edu

Mount Sinai Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CCTO@mssm.edu

Mount Sinai Union Square
Status: ACTIVE
Contact: Site Public Contact
Email: CCTO@mssm.edu

Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact

OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@uchealth.com

West Chester
University of Cincinnati Cancer Center-West Chester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@uchealth.com

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

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

PA
Beaver
UPMC-Heritage Valley Health System Beaver
Status: ACTIVE
Contact: Site Public Contact
Email: haneydl@upmc.edu

Carlisle
Carlisle Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Erie
UPMC Hillman Cancer Center Erie
Status: ACTIVE
Contact: Site Public Contact
Email: haneydl@upmc.edu

Farrell
UPMC Cancer Center at UPMC Horizon
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact

Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: ACTIVE
Contact: Site Public Contact
Email: klitchfield@PINNACLEHEALTH.org

Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Email: haneydl@upmc.edu

Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact

New Castle
UPMC Jameson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

Pittsburgh
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact

UPMC-Presbyterian Hospital
Status: ACTIVE
Contact: Site Public Contact

UPMC-Shadyside Hospital
Status: ACTIVE
Contact: Site Public Contact

University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact

Washington
UPMC Washington Hospital Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@washingtonhospital.org

York
UPMC Memorial
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

VA
Fairfax
Inova Schar Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Falls Church
Inova Fairfax Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

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

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

Milwaukee
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

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

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

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

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

Weston
Diagnostic and Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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

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

PRIMARY OBJECTIVES:
I. Evaluate the structure preservation rate for patients with locally advanced resectable nasal and paranasal sinus squamous cell carcinoma (NPNSCC) with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care.
II. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care.

SECONDARY OBJECTIVES:
I. Evaluate progression-free survival (PFS) for this patient population.
II. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration).
III. Evaluate site reported p16 data and correlate with outcome.
IV. Determine the accuracy of baseline/post-chemotherapy magnetic resonance imaging (MRI) and/or fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation.
V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival.

EXPLORATORY TOBACCO USE OBJECTIVES:
I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose modifications).
II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.
III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization.
IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided intensity modulated radiation therapy (IMRT) once daily (QD) for 5 fractions per week for 30 fractions. Patients with positive margins/positive extracapsular spread (ECS) in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin intravenously (IV) over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if < 2 years from study entry and then every 6 months if 2-5 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.


EA3163 Home Page
ECOG-ACRIN Cancer Research Group