Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma|
- Failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
- Overall survival, distant failure-free survival and locoregional failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Concurrent and adjuvant
Concurrent chemoradiotherapy plus adjuvant chemotherapy
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.
Other Name: Cisplatin and fluorouracil
Active Comparator: Concurrent
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.
Other Name: Cisplatin
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Jun Ma, M.D.||Sun Yat-sen University|