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NRG-HN001


Title Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Therapeutic Area Head and Neck Cancer
Principal Investigator Robert Martell, MD
Min Age 18 Years
Gender Both
Contact Madeleine Arthur
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT02135042

Overview

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. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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 Details

Inclusion Criteria

  • Must have diagnosis of  cancer of the nasopharynx (the upper part of the throat behind the nose and near the base of skull)
  • Must have adequate organ functions
  • Must have detectable plasma EBV DNA

Exclusion Criteria

  • Must not have had prior systemic chemotherapy for nasopharynx cancer
  • Must not have had a prior invasive malignancy or cancer
  • Must not be pregnant or unwilling to use medically acceptable forms of contraception

Study Requirements

Subjects wishing to enroll into the study must provide 1-2 teaspoons of blood once before chemotherapy and once after chemotherapy for EBV DNA detection. Subjects will also be asked to fill out quality of life surveys at 5 time points during the study. Scans, such as a MRI and/or PET/CT, will be performed before the study begins, 4 months after radiation therapy, and one year after radiation therapy. Length of study treatment is approximately 12 weeks; however follow up will occur once every 4 months for 2 years then once every 6 months for 3 years.