A Randomised Phase ll/Lll Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer
- To compare the 5-year overall survival of patients with locally advanced nasopharyngeal
cancer treated with concurrent cisplatin and radiotherapy with vs without induction
chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.
- To assess and compare the disease-free survival, distant metastases rate, toxicities,
and quality of life of patients treated with these regimens.
OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2
- Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo
intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for
a total of 33 fractions).
- Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV
over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1
and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after
the last dose of induction chemotherapy, patients receive cisplatin and undergo
radiotherapy as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 2 months for 1 year, every
4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall survival at 5 years
Terence Tan, FRCR
National Cancer Centre, Singapore