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

Trial Status: Active

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.

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

Alabama

Birmingham
The Kirklin Clinic at Acton Road
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 205-934-0220
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Burlingame
Mills-Peninsula Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
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
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 858-822-5354
Modesto
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
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: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Palo Alto
Palo Alto Medical Foundation Health Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
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
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
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
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
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
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686

Colorado

Greeley
North Colorado Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Parker
Parker Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Wheat Ridge
SCL Health Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

Connecticut

New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-202-7468
Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-679-0775

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory Saint Joseph's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671

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
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
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

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
Wesley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Maryland

Baltimore
Greater Baltimore Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-849-3706
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804

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: ACTIVE
Contact: Site Public Contact
Phone: 617-636-5000

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Bay City
McLaren Cancer Institute-Bay City
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Clarkston
McLaren Cancer Institute-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Farmington Hills
Weisberg Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Flint
McLaren Cancer Institute-Flint
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Singh and Arora Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Lansing
McLaren-Greater Lansing
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Mid-Michigan Physicians-Lansing
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Mount Clemens
McLaren Cancer Institute-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Pontiac
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Port Huron
McLaren-Port Huron
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

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
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
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
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
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
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

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: 732-235-7356
Newark
Rutgers New Jersey Medical School
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Brooklyn
Maimonides Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-765-2500
New York-Presbyterian / Brooklyn Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-780-3677
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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-263-4434
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: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361
New York Proton Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 646-968-9031
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Sleepy Hollow
Memorial Sloan Kettering Sleepy Hollow
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7202
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

Akron
Cleveland Clinic Akron General
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Chardon
Geauga Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Elyria
Mercy Cancer Center-Elyria
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sandusky
North Coast Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
West Chester
University Pointe
Status: ACTIVE
Contact: Site Public Contact
Westlake
UHHS-Westlake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100

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

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
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

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
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

Puerto Rico

San Juan
Centro Comprensivo de Cancer de UPR
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Utah

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

Virginia

Fairfax
Inova Schar Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 703-720-5210
Falls Church
Inova Fairfax Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 703-208-6650
Portsmouth
Naval Medical Center - Portsmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-953-5939

Washington

Vancouver
Legacy Salmon Creek Hospital
Status: ACTIVE
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: 920-433-8889
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
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
Milwaukee
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Ascension Saint Michael's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Weston
Diagnostic and Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-799-3989

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

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
The Research Institute of the McGill University Health Centre (MUHC)
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-934-1934ext48354

Australia

Melbourne
Peter MacCallum Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 61 3 9656 1521

China

Guangdong Province
Zhongshan Hospital Fudan University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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

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 Singapore
Status: ACTIVE
Contact: Site Public Contact
Phone: 65 6225 5655

Taiwan

Taipei
National Taiwan University Hospital
Status: ACTIVE
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

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 Phase II/III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Nancy Y. Lee

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