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NRG-HN001

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, MD

Primary Objectives

  • 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

  • Randomized phase II: 126
  • Phase III: 632

Status

Activated  4/21/2014

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

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Copyright 2017 by NRG Oncology