Study for Patients With Non Small Cell Lung Cancer (NSCLC)
Phase 2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00168883
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.
- Detailed Description
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV
Exclusion Criteria
- New York Heart Association (NYHA) III or IV
- Brain metastases
- Neurotoxicity Grade 2 or greater
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determination of response rate (stable disease [SD] or better) Determination of safety of the combination and life quality
- Secondary Outcome Measures
Name Time Method Determination of remission rate Determination of time to progression Determination of 1-year survival rate
Trial Locations
- Locations (1)
Hematology & Oncology Charité CBF Berlin
🇩🇪Berlin, Germany