Full TitleRandomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA) (NRG HN001) (CIRB)
The standard treatment for nasopharyngeal cancer is chemotherapy with the drug cisplatin plus radiation therapy, followed by more chemotherapy. Doctors are seeking ways to personalize treatment for nasopharyngeal cancer based on a blood marker called Epstein-Barr virus (EBV) DNA. EBV has been associated with nasopharyngeal cancer development and progression.
In this study, patients with nasopharyngeal cancer whose blood contains EBV DNA will first be treated with six weeks of cisplatin and radiation therapy. Patients’ blood will then be tested again when that treatment is completed, and they will be randomly assigned to one of four groups:
- Patients whose blood still contains EBV DNA, indicating they have a high risk of the cancer spreading, will then receive either cisplatin and 5-fluorouracil (group 1, the standard additional chemotherapy) or gemcitabine and paclitaxel (group 2, an investigational treatment) for 12 weeks.
- Patients whose blood no longer contains EBV DNA will either receive standard cisplatin and 5-fluoruracil for 12 weeks (group 3) or no additional treatment (group 4).
Researchers will compare the patients in the different groups to see how well they do. All of the drugs in this study are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have nasopharyngeal cancer that has not spread to other parts of the body and has not yet been treated with radiation therapy or chemotherapy.
- Patients’ blood must contain EBV DNA.
- This study is for patients age 18 and older.