Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Sponsor: |
NRG Oncology |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS1064 |
U.S. Govt. ID: |
NCT02135042 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
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 blood, then patients are randomized to either 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.
This study is closed
Investigator
Matthen Mathew, MD
Are you 18 years of age or older? |
Yes |
No |
Have you been diagnosed with nasopharynx cancer with no distant metastasis? |
Yes |
No |
Have you had no prior chemotherapy or radiotherapy for your disease? |
Yes |
No |