Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer
The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer|
- one year survival rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The primary endpoint is designated to evaluate overall survival rate at 12-month. Secondary endpoints include response rate according to RECIST 1.1 and the incidence of adverse events evaluated by CTCAE v 4.0.
- Toxicity and response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: S-1, Gemcitabine, Cisplatin||
Drug: S-1, Gemcitabine, Cisplatin
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Other Name: S-1;TS-1, Gemcitabine;gemzer, Cisplatin;Cispulan
Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery representing the only potentially curative treatment for this disease. However, many patients are diagnosed too late for curative resection, and even if surgery can be performed, the likelihood of relapse is very high. Over the past decade, gemcitabine has been widely used to treat unresectable or recurrent biliary tract cancer patients. In the ABC-02 study, the first prospective multicenter phase III study in this field, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and found that the combination regimen significantly prolonged MST (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for advanced biliary tract cancer. S-1 is an oral fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors, both alone and in combination with other cytotoxic drugs. S-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabine/S-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer. In this study, we aimed to determine the safety and efficacy of adding S-1 to gemcitabine/cisplatin combination regimen for advanced biliary tract cancer.