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)

Principal Investigator

Nancy Lee

Status

Disease Site

Head and Neck [HN] Head and Neck

Phase

II/III

Developmental Therapeutics

No

Primary Objective

• Detectable Plasma EBV DNA Cohort (randomized phase II): The primary objective is to determine whether substituting adjuvant CDDP and 5-FU with gemcitabine and paclitaxel will result in superior progression-free survival.
• Undetectable Plasma EBV DNA Cohort (phase III): The primary objective is to determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in noninferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy.

Patient Population

Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of stage II-IVB non-metastatic cancer of the nasopharynx; detectable pre-treatment plasma EBV DNA

Target Accrual

924