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

Phase 3

Completed

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT02940925
• Lead Sponsor: Sun Yat-sen University

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 Description

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 Timeline

• Study First Submitted: 2016-09-21
• Study Start: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2021-08-28
• Study Completion: 2021-08-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• WHO II or III pathological type
• stage Ⅳa or Ⅳb (UICC 7th edition)
• no anticancer treatment before
• no malignant history
• both gender, 18-60 years old
• enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
• enough kidney function: Clcr≥80 mL/min
• enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
• no sever heart, lung disfunction
• PS≤2

Exclusion Criteria

• previous anticancer treatment
• distant metastasis
• pregnant or breasting female
• can not access to followup
• enrolled in other therapeutic clinical trial
• sever infection and internal disease
• sever disfunction of heart, lung, kidney, liver, etc
• TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
• with factors that will affect the administration, distribution,metabolism or evacuation.
• using immunosuppressive agents after organ transplantation
• other malignant history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Local-regionally relapse free survival calculated from randomisation to locoregional failure	up to 5 years
Progression free survival calculated from randomisation to disease progression or death from any cause	up to 5 years
Overall survival calculated from randomisation to death from any cause	up to 5 years
Distant metastasis free survival calculated from randomisation to distant failure	up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 5 years

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China