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
Drug: epirubicin, cisplatin, LV, 5-FU
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 and PR [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9, CEA et al, especially for those which are abnormal prior to chemotherapy [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: epirubicin,cisplatin,LV,5-FU
|Drug: epirubicin, cisplatin, LV, 5-FU|
Conventional chemotherapy regimen plus somatostatin
Somatostatin 3mg+NS60ml, a continuous intravenous infusion, q12hDrug: epirubicin, cisplatin, LV, 5-FU
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 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 (RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event
Physical exam, laboratory test, probably occurred adverse event.
|Contact: Zhao-hui Tang, MD||86-21-65790000 ext firstname.lastname@example.org|
|Xinhua hospital affiliated shanghai jiaotong||Recruiting|
|Contact: Zhao-hui Tang, MD 86-21-65790000 ext 7905 email@example.com|
|Study Chair:||Zhi-wei Quan, MD||Xinhua hospital affiliated shanghai jiaotong university school of medicine|