Clinical Trial: New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) [ Time Frame: 6 month after first treatment ]

Original Primary Outcome: Response Evaluation Criteria in Solid Tumors, RECIST,2009 CR and PR [ Time Frame: 6 month ]

Current Secondary Outcome: 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 ]

Original Secondary Outcome: 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 ]

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: January 20, 2010
Date Started: October 2009
Date Completion:
Last Updated: December 18, 2013
Last Verified: December 2013