Individualized Treatment in Treating Patients with Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

Status: Active

Description

There are two study questions we are asking in this randomized phase II / III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Eligibility Criteria

Inclusion Criteria

  • Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
  • Sites are required to complete Step 1 registration before submitting specimens for EBV DNA analysis * Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration * For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs within 28 days prior to Step 1 registration: that test result can be used for eligibility without the need for re-testing; to use this test result for eligibility, the central lab must enter the test result through the pathology portal
  • Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup: * History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration * Evaluation of tumor extent required within 28 days prior to registration: ** Magnetic resonance imaging (MRI) of the nasopharynx and neck; or computed tomography (CT) of the nasopharynx and neck with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement). *** Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist * To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration: ** A CT scan with contrast of the chest and abdomen (required), and the pelvis (optional), or a total body PET/CT scan (non-contrast PET/CT is acceptable) ** A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
  • Zubrod performance status 0-1 within 21 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 21 days prior to registration)
  • Platelets >= 100,000 cells/mm^3 (within 21 days prior to registration)
  • Hemoglobin >= 8.0 g/dl (within 21 days prior to registration) (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 21 days prior to registration)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN (within 21 days prior to registration)
  • Alkaline phosphatase =< 1.5 x institutional ULN (within 21 days prior to registration)
  • Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula (within 21 days prior to registration)
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
  • Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

Exclusion Criteria

  • Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
  • >= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
  • Severe, active co-morbidity, defined as follows: * Major medical or psychiatric illness, which in the investigator’s opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy * Unstable angina and/or uncontrolled congestive heart failure within past 6 months * Myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • Patients with undetectable pre-treatment plasma EBV DNA

Locations & Contacts

Alabama

Birmingham
The Kirklin Clinic at Acton Road
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Burlingame
Mills-Peninsula Medical Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Dublin
Kaiser Permanente Dublin
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Fresno
Fresno Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Modesto
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Oakland
Kaiser Permanente Oakland-Broadway
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Site Public Contact
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
South Sacramento Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
UCSF Medical Center-Mount Zion
Status: Active
Contact: Site Public Contact
Phone: 877-827-3222
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Pasadena
City of Hope South Pasadena
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado

Greeley
North Colorado Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Parker
Parker Adventist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Florida

Tampa
Moffitt Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory Proton Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 404-251-2854
Email: allyson.anderson@emory.edu
Emory Saint Joseph's Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Active
Contact: Site Public Contact
Phone: 888-946-7447

Hawaii

Aiea
The Cancer Center of Hawaii-Pali Momi
Status: Active
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-547-6881

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kansas

Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Wesley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-849-3706
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Boston Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-638-8265
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Tufts Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Livonia
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Reno
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Saint Mary's Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-780-3677
Email: Adg9003@nyp.org
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592

Ohio

Chardon
Geauga Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Elyria
Mercy Cancer Center-Elyria
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sandusky
North Coast Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Approved
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Approved
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org

Pennsylvania

Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

South Carolina

Greenville
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 801-855-4100
Email: officeofresearch@imail.org
Cedar City
Sandra L Maxwell Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-868-5680
Email: officeofresearch@imail.org
Murray
Intermountain Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Provo
Utah Valley Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Riverton
Riverton Hospital
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Status: Active
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org

Virginia

Fairfax
Inova Schar Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 703-720-5210
Email: Stephanie.VanBebber@inova.org
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Portsmouth
Naval Medical Center - Portsmouth
Status: Active
Contact: Site Public Contact
Phone: 757-953-5939

Washington

Vancouver
Legacy Salmon Creek Hospital
Status: Approved
Contact: Site Public Contact
Phone: 503-413-2150

Wisconsin

Eau Claire
HSHS Sacred Heart Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-717-3956
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Saint Michael's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org

Alberta

Calgary
Tom Baker Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 780-432-8500

Ontario

London
London Regional Cancer Program
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 519-685-8600
Toronto
University Health Network-Princess Margaret Hospital
Status: Active
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec

Montreal
Jewish General Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-340-8222ext8248
McGill University Department of Oncology
Status: Active
Contact: George Shenouda
Phone: 514-934-1934extn42953
Email: evelyn.ortega@muhc.mcgill.ca
The Research Institute of the McGill University Health Centre (MUHC)
Status: Active
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Email: evelyn.ortega@muhc.mcgill.ca

China

Guangdong Province
Zhongshan Hospital Fudan University
Status: Active
Contact: Site Public Contact
Phone: (8621) 64175590 X 81112
Guangzhou
Sun Yat-sen University Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 86 20 87343571
Shatin
Chinese University of Hong Kong-Prince of Wales Hospital
Status: Active
Contact: Site Public Contact
Email: ccrb@cuhk.edu.hk

Hong Kong

Chai Wan
Pamela Youde Nethersole Eastern Hospital
Status: Active
Contact: Site Public Contact
Phone: 011 852 2595 7920

Singapore

Singapore
National Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 65 6225 5655
Email: cancerhelpline@nccs.com.sg

Taiwan

Taipei
National Taiwan University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 886-2-2312-3456
Taoyuan
Chang Gung Hospital-Lin Kou Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine whether substituting adjuvant concurrent high dose cisplatin (CDDP) and fluorouracil (5-FU) with gemcitabine (gemcitabine hydrochloride) and paclitaxel will result in superior progression-free survival. (Detectable Plasma Epstein Barr Virus [EBV] Deoxyribonucleic Acid [DNA] Cohort randomized Phase II)

II. To determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in non-inferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy. (Undetectable Plasma EBV DNA Cohort Phase III)

SECONDARY OBJECTIVES:

I. Time to distant metastasis. (Randomized Phase II and Phase III)

II. Time to local progression. (Randomized Phase II and Phase III)

III. Time to regional progression. (Randomized Phase II and Phase III)

IV. Progression-free survival (Undetectable Cohort).

V. Overall survival (Detectable Cohort).

VI. Acute and late toxicity profiles based on clinician-reported Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4. (Randomized Phase II and Phase III)

VII. Death during or within 30 days of end of protocol treatment. (Randomized Phase II and Phase III)

VIII. Quality of life (general and physical well-being). (Randomized Phase II and Phase III)

IX. Quality of life (hearing). (Randomized Phase II and Phase III)

X. Quality of life (peripheral neuropathy). (Randomized Phase II and Phase III)

XI. Cost effectiveness. (Randomized Phase II and Phase III)

OUTLINE:

Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6.5 to 7 weeks and receive low-dose cisplatin intravenously (IV) over 30-60 minutes or high-dose cisplatin IV over 3 hours once weekly during IMRT. Beginning 1 week after chemoradiation, plasma samples are collected for EBV DNA analysis.

PHASE II: Patients with detectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms.

ARM I: Patients receive PF regimen comprising cisplatin IV over 60-180 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PHASE III:

Patients with undetectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms.

ARM III: Patients receive PF regimen as in Arm I.

ARM IV: Patients undergo clinical observation.

After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Nancy Y. Lee

Trial IDs

Primary ID NRG-HN001
Secondary IDs NCI-2014-00635, RTOG-1305, s16-00025, NCT02179164
Clinicaltrials.gov ID NCT02135042