Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01375972|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : December 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Biliary Cancer||Drug: S-1 plus cisplatin Drug: Gemcitabine plus Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer|
|Study Start Date :||March 2008|
|Primary Completion Date :||July 2011|
|Study Completion Date :||August 2011|
Experimental: SP treatment
S-1 plus cisplatin combination chemotherapy
Drug: S-1 plus cisplatin
S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
Active Comparator: GP treatment
Gemcitabine plus Cisplatin combination chemotherapy
Drug: Gemcitabine plus Cisplatin
Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
- Progression-free survival rate at 6 months [ Time Frame: 6 months ]progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.
- Response rate [ Time Frame: 6 months ]Response to chemotherapy will be assessed using RECIST 1.0 criteria.
- Toxicities [ Time Frame: Up to 24 months ]Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described.
- overall survival [ Time Frame: up to 36 months ]Overall survival is calculated from the date of enrollment to the date of death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375972
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138736|
|Study Director:||MJ Kang, MD, MSc||Asan Medical Center|