NRG Oncology 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)

SUMMARY

 

You are being asked to take part in this study because you have nasopharyngeal cancer (in the head and neck region of your body) that has not spread to other parts of your body.

 

This study is being done to see how people with your type of cancer respond to different types or levels of chemotherapy, based on a specific viral marker in their blood. This viral marker is called the Epstein Barr virus, (EBV). A more individualized approach to treating your type of cancer might be found using this blood marker.

There will be about 126 people taking part in Groups 1 and 2 and 632 taking part in Groups 3 and 4.

People who are not in a study are usually treated with radiation and chemotherapy given together followed by additional chemotherapy. There are several FDA-approved chemotherapy drugs that are commonly used as part of this treatment. For patients who receive the usual approach for this cancer, on average 70 patients out of 100 are free of cancer at five years.

COH Protocol Number : 14258

ClinicalTrials.gov Number : NCT02135042

Principal Investigator : Vora, Nayana M.D.

Sponsor : NRG Oncology

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : N/A

Gender : Either

Minimum Performance Status : Zubrod:0

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :