Clinical Trial: Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Brief Summary:
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Goals
- The primary goal of this phase II trial is to:
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy
Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
- Design
The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22
Detailed Summary:
Sponsor: Korean South West Oncology Group
Current Primary Outcome: Response rate [ Time Frame: 2years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Treatment-related toxicities [ Time Frame: 2 years ]Number and proportion of patients with adverse events according to the NCI-CTCAE (v 4.0) as a measure of treatment-related toxicities
- Progression free survival [ Time Frame: 2 years ]
Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves.
The median PFS and OS will be used for measure.
- Overall survival [ Time Frame: 2 years ]
Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves.
The median PFS and OS will be used for measure.
Original Secondary Outcome: Same as current
Information By: Korean South West Oncology Group
Dates:
Date Received: October 28, 2010
Date Started: November 2010
Date Completion: December 2013
Last Updated: December 9, 2011
Last Verified: November 2010
