Clinical Trial: A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment
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 stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment
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 two-stage testing procedure
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:
- Overall survival [ Time Frame: 2years ]Overall survival will be calculated by Kaplan-Meier method
- Progression free survival [ Time Frame: 2 years ]Progression free survival will be calculated by Kaplan-Meier method
- Number of Participants with Adverse Events [ Time Frame: 2 years ]Assessment of toxicity will be assessed according to CTCAE version 4.0
- Quality of life [ Time Frame: 2 years ]Quality of life will be assessed according to EORTC QLQ-C30, LC13
Original Secondary Outcome: Same as current
Information By: Korean South West Oncology Group
Dates:
Date Received: December 14, 2011
Date Started: February 2011
Date Completion: December 2013
Last Updated: December 19, 2011
Last Verified: December 2011