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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Other: Drug: Taxol,cisplatin and capecitabine
* Other: Drug: Cisplatin and 5-Fluorouracil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Taxol,cisplatin and capecitabine<br>Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT). | Other: Drug: Taxol,cisplatin and capecitabine<br>* Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.<br>|
| Active Comparator: Drug: Cisplatin and 5-Fluorouracil<br>Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy. | Other: Drug: Cisplatin and 5-Fluorouracil<br>* Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival calculated from randomisation to death from any cause |  | up to 5 years | 
| Progression free survival calculated from randomisation to disease progression or death from any cause |  | up to 5 years | 
| Local-regionally relapse free survival calculated from randomisation to locoregional failure |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, induction chemotherapy