Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
Run by NRG Oncology · NCT02135042 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2029-01-31.
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 rand…
Quick facts
| Phase | Phase 2/3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 924 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | Bone Scan, Cisplatin, Clinical Observation, Computed Tomography, Fluorouracil, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Paclitaxel, Positron Emission Tomography, Quality-of-Life Assessment |
| Locations | 213 sites (Australia, Canada, China, Hong Kong, Puerto Rico, Singapore, Taiwan, United States) |
| Trial ID | NCT02135042 on ClinicalTrials.gov |
What this trial studies
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 a…
Who can join: the full rules
Show full inclusion / exclusion 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
* 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
Where it's running
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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
Show 44 more locations
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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
+163 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Nancy Y Lee — NRG Oncology
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.