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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Best supportive care and following-up every 6-8 weeks
SunYat-senU
Guangzhou, Guangdong, China
progression-free survival
the time from randomization to the progression of disease
Time frame: up to 6 years
overall survival
the time from randomization to death
Time frame: up to 6 years
duration of response
the time from the date of the first cycle of chemotherapy to the progression of disease
Time frame: up to 6 years
objective response rate
CR, PR and SD rate
Time frame: up to 6 years
adverse effects
chemotherapy side effects
Time frame: up to 6 years
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
evaluate with FACT-H\&N every 3 months after randomiztion
Time frame: up to 6 years
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