NRG-HN001, Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

General Information Age Group Adults Status Recruiting Protocol Number NCT02135042 Background Information This study was designed to help 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. This study may also help 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)   Offered At Inova Fairfax Hospital 3300 Gallows Road Fairfax, VA 22031 Inova Schar Cancer Institute 8081 Innovation Park Drive Fairfax, VA 22031 A department of Inova Fairfax Hospital Eligibility Information Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx Additional eligibility in protocol Ineligibility Information 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; Greater than grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0) Additional exclusions in protocol For more information go to: https://clinicaltrials.gov/ct2/show/NCT02135042 Contact Information Contact Name Shanae Henry Contact Phone 571-472-0233 Contact Email Send Email