Clinical Trial: Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

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

Official Title: Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

Brief Summary: The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.

Detailed Summary: 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.
Sponsor: Kansai Hepatobiliary Oncology Group

Current Primary Outcome: one year survival rate [ Time Frame: 2 years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Toxicity and response rate [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Kansai Hepatobiliary Oncology Group

Dates:
Date Received: January 3, 2011
Date Started: December 2010
Date Completion:
Last Updated: June 29, 2014
Last Verified: June 2014