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

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Brief Title

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

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 Clinical Trial

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause

Secondary Outcome

 Overall survival calculated from randomisation to death from any cause

Condition

Nasopharyngeal Carcinoma

Intervention

Drug: Taxol,cisplatin and capecitabine

Study Arms / Comparison Groups

 Drug: Taxol,cisplatin and capecitabine
Description:  Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

220

Start Date

September 2016

Completion Date

August 27, 2024

Primary Completion Date

October 14, 2019

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Yanqun Xiang, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02940925

Organization ID

20160049

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

Yanqun Xiang, Study Chair, Sun Yat-sen University

Verification Date

October 2019