A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small-cell lung cancer patients with high-risk for recurrence: NVALT 8B
Recruiting
- Conditions
- on-small-cell lung cancer
- Registration Number
- NL-OMON24423
- Lead Sponsor
- MCGHanzeplein 19700 RB Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
2. SUVmax >- 10
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.