Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT00677118|
Recruitment Status : Unknown
Verified March 2010 by Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : May 13, 2008
Last Update Posted : July 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: Cisplatin,fluorouracil Drug: Cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
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.
- Failure-free survival [ Time Frame: 2-yr ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677118
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Jun Ma, M.D.||Sun Yat-sen University|