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Head and Neck
General Information
Study Name:
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)
Age Group:
Adult
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
Contact Information
Contact Name:
Shelby Dukes
Contact Phone:
571-472-0624
Contact Email:
shelby.dukes@inova.org