The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.
This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS).The secondary endpoints are overall survival(OS),progression-free survival(PFS), local-regionally relapse free survival(LRFS), distant metastasis free survival(DMFS)and toxicities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
SunYat-senU
Guangzhou, Guangdong, China
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
Time frame: up to 5 years
Overall survival calculated from randomisation to death from any cause
Time frame: up to 5 years
Progression free survival calculated from randomisation to disease progression or death from any cause
Time frame: up to 5 years
Local-regionally relapse free survival calculated from randomisation to locoregional failure
Time frame: up to 5 years
Distant metastasis free survival calculated from randomisation to distant failure
Time frame: up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 5 years
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