Clinical Trial: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Cl

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause [ Time Frame: up to 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: September 21, 2016
Date Started: September 2016
Date Completion: August 2024
Last Updated: October 20, 2016
Last Verified: October 2016