Spots Global Cancer Trial Database for New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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Trial Identification

Brief Title: New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Official Title: A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Study ID: NCT01053390

Conditions

Gallbladder Neoplasms

Interventions

Somatostatin

epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Study Description

Brief Summary: Objective Primary: Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen Secondary: Determine time to progression-free survival and overall survival of patients treated with this regimen. Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen

Detailed Description: Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study Chemotherapy regimen: Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total Patients: A total of 260 patients (130 per group) will be accrued for this study. Patients distribution: 10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial. Clinical Outcome Assessments: Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event Safety Assessments: Physical exam, laboratory test, probably occurred adverse event.