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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Other: Drug: Taxol,cisplatin and capecitabine; Other: Drug: Cisplatin and 5-Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT02940925

20160049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

Drug: Taxol,cisplatin and capecitabine

Experimental group

Description:

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

Treatment:

Other: Drug: Taxol,cisplatin and capecitabine

Drug: Cisplatin and 5-Fluorouracil

Active Comparator group

Description:

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

Treatment:

Other: Drug: Cisplatin and 5-Fluorouracil