New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen
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
|Gallbladder Neoplasms||Drug: Somatostatin Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma|
- (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) [ Time Frame: 6 month after first treatment ]
- A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9（Carbohydrate Antigen 19-9）、 CEA（ carcinoembryonic antigen）, especially for those which are abnormal prior to chemotherapy [ Time Frame: 6 month after first treatment ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil)
|Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）|
Conventional chemotherapy regimen plus somatostatin
Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12hDrug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study
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.
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
Physical exam, laboratory test, probably occurred adverse event.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053390
|Xinhua hospital affiliated shanghai jiaotong|
|Study Chair:||Zhi-wei Quan, MD||Xinhua hospital affiliated shanghai jiaotong university school of medicine|