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:

  1. 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

  2. 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 ]

Assessment of response will be assessed according to RECIST v1.1 criteria


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