Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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|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.
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): NCT00677118
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Jun Ma, M.D.||Sun Yat-sen University|