A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
Rationale of induction chemotherapy:
Distant metastasis is the major cause of treatment failure and deaths in patients with
loco-regionally advanced NPC.
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is
still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant
metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of
patients with advanced NPC.
Investigate the effect of induction MEPFL chemotherapy followed by concurrent
chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with
This is a randomized, multi-center Phase III study. Patients will be randomized to CCRT with
or without the MEPFL induction chemotherapy.
Type and number of patients:
Patients with stage IVA (T4) and/or IVB (N3) but without distant metastasis will be
enrolled. A total of up to 480 patients will be randomized to detect an improvement of
median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a
two-sided logrank test with one interim analysis.
Induction chemotherapy and CCRT:
Arm A: Weekly cisplatin concurrently with radiotherapy Arm B: Induction MEPFL three cycles
followed with weekly cisplatin concurrently with radiotherapy.
The primary endpoint is the disease-free survival that will be calculated as the duration
between the date of randomization and the date of recurrence of NPC at any site including
persistent disease after +induction chemotherapy/CCRT, or death from any cause (failed), or
the date of withdrawal (last contact date, censored), or the scheduled data analysis date
(censored).( revised 8/27/2004)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the disease-free survival.
Ruey-Long Hong, MD, PhD
Taiwan cooperative oncology group
Taiwan: Department of Health