Clinical Trial: Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma

Brief Summary: To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.

Detailed Summary: To list in cases with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing evidence-based proof for the future treatment.
Sponsor: Beijing Cancer Hospital

Current Primary Outcome: objective response rate [ Time Frame: 2 years ]

to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)


Original Primary Outcome: Same as current

Current Secondary Outcome: overall survival [ Time Frame: 2 years ]

to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)


Original Secondary Outcome: Same as current

Information By: Beijing Cancer Hospital

Dates:
Date Received: August 9, 2010
Date Started: August 2010
Date Completion: August 2012
Last Updated: August 11, 2010
Last Verified: August 2010