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. 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. Study Arms: Active Comparator: Arm I (chemoradiation, cisplatin, fluorouracil) Patients receive PF regimen comprising cisplatin IV over 60-120 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. Experimental: Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel) 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. 3) Active Comparator: Arm III (chemoradiation, cisplatin, fluorouracil) Patients receive PF regimen as in Arm I of Phase II. 4) Experimental: Arm IV (chemoradiation, observation) Patients undergo clinical observation.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
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