Clinical Trial: Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
Brief Summary: This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
Detailed Summary: Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.
Sponsor: Sun Yat-sen University
Current Primary Outcome: progression-free survival [ Time Frame: up to 6 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- overall survival [ Time Frame: up to 6 years ]
- duration of response [ Time Frame: up to 6 years ]
- objective response rate [ Time Frame: up to 6 years ]
- adverse effects [ Time Frame: up to 6 years ]
- quality of life [ Time Frame: up to 6 years ]
Original Secondary Outcome: Same as current
Information By: Sun Yat-sen University
Dates:
Date Received: May 23, 2015
Date Started: April 2015
Date Completion: May 2021
Last Updated: May 2, 2017
Last Verified: May 2017
