lung cancer Non-small cell lung cancer
Conditions
Interventions
Within 4-6 weeks after surgery all patients will receive 4 cycles of pemetrexed
(500 mg/m2) and cisplatin (75 mg/m2) on day 1 every 3 weeks. Patients in de
nadroparin arm will receive nadroparin s.c
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with resectable NSCLC - SUVmax >= 10 - Age >= 18 years - WHO Performance score = 1.5 x 109/L, platelets >= 100 x 109/L. Hepatic: bilirubin = 60 ml/min based on the Cockroft and Gault formula. INR
Exclusion criteria
Exclusion criteria: - Patients with stage IA NSCLC - Prior chemotherapy or radical radiotherapy for NSCLC. - Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease). - Concomitant treatment with any other experimental drug under investigation. - Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam). - Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone. - History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non-melanoma skin cancer or in situ cervical cancer. - Pregnancy - Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed - Indication for anticoagulant treatment. - Any contraindication listed in the labeling of nadroparin. - Documented history of heparin-induced thrombocytopenia with UFH or LMWH - Current active bleeding or judged to be as high risk of bleeding;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is recurrence-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed