A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin
- The standard treatment for nasopharynx cancer is a course of radiotherapy with or
without concurrent chemotherapy. This will cure about 80% of patients. For the 20% who
developed recurrence or metastases, the prognosis is poor.
- Elevated EBV-DNA in plasma at end of radiotherapy has been shown to predict disease
recurrence and may be a marker of subclinical residual disease.
- This study aims to test whether adjuvant treatment with 6 cycles of a modern
chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival
of these high risk patients of nasopharynx cancer who have elevated EBV-DNA after
completion of their radiotherapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse free survival
Anthony TC Chan, MD, FRCP
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
Hong Kong: Department of Health