Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, induction chemotherapy
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.
Interventions
OTHERDrug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
OTHERDrug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause | up to 5 years |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed