NCT01053390

New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gallbladder Neoplasms

Interventions

Type	Name	Description
DRUG	Somatostatin	Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
DRUG	epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-01-21
• Last updated: 2013-12-20

Locations

1 site across 1 country: China