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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug: Taxol,cisplatin and capecitabine

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

Group Type EXPERIMENTAL

Drug: Taxol,cisplatin and capecitabine

Intervention Type OTHER

Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Drug: Cisplatin and 5-Fluorouracil

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Group Type ACTIVE_COMPARATOR

Drug: Cisplatin and 5-Fluorouracil

Intervention Type OTHER

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Interventions

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Drug: Taxol,cisplatin and capecitabine

Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Intervention Type OTHER

Drug: Cisplatin and 5-Fluorouracil

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No