A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence
Suspended
- Conditions
- non-small-cell lung cancer
- Registration Number
- NL-OMON27925
- Lead Sponsor
- VALT oncology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 864
Inclusion Criteria
1. Age >= 18 years
2. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
Exclusion Criteria
1. Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection.
2. Prior chemotherapy or radical radiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint is recurrence-free survival.
- Secondary Outcome Measures
Name Time Method Secundary end-points are overall survival, dose intensity of subsequent cycles, quality of life, toxicity, health economics. Exploratory endpoints are analysis of blood and tumor samples for prognostic markers, genomics/proteomics.