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ACTIVE NOT RECRUITING

NCT02135042

PHASE2/PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

924

Start Date

2014-07-01

Completion Date

2034-01-01

Last Updated

2026-10-13

Healthy Volunteers

Conditions

EBV Infection Stage II Nasopharyngeal Carcinoma AJCC v7 Stage III Nasopharyngeal Carcinoma AJCC v7 Stage IVA Nasopharyngeal Carcinoma AJCC v7 Stage IVB Nasopharyngeal Carcinoma AJCC v7

Interventions

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cisplatin

Given IV

OTHER

Clinical Observation

Undergo clinical observation

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

OTHER

Quality-of-Life Assessment

Ancillary studies

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 * Age \>= 18 * 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) and 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 (213)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

The Kirklin Clinic at Acton Road

Birmingham, Alabama, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Fresno Cancer Center

Fresno, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Memorial Medical Center

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Yale University

New Haven, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

McLaren-Port Huron

Port Huron, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

And 113 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (213)