A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00201396|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Radiation: CCRT Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin||Phase 3|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||December 2011|
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
- The primary endpoint is the disease-free survival. [ Time Frame: 10 years ]follow up for 2 years after off study treatment
- Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 10 years ]follow up for 2 years after off study treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|