A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)|
- The primary endpoint is the disease-free survival. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]follow up for 2 years after off study treatment
- Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 10 years ] [ Designated as safety issue: No ]follow up for 2 years after off study treatment
|Study Start Date:||August 2003|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A arm
Radiation with weekly Cisplatin
Experimental: B arm
Radiation with weekly CisplatinDrug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
Induction C/T + CCRT
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 advanced NPC.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201396
|Kaohsiung Medical University Hospital|
|Kaohsiung, Taiwan, 80708|
|China Medical University Hospital|
|Taichung, Taiwan, 40447|
|National Taiwan University Hospital|
|Taipei, Taiwan, 115|
|Chang-Gung Memorial Hospital(Lin-Kou),|
|Taoyuan, Taiwan, 333|
|Principal Investigator:||Ruey-Long Hong, MD, PhD||Taiwan cooperative oncology group|