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
UMCG
Hanzeplein 1
9700 RB Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1 2. SUVmax >- 10 3. Patients with NSCLC who had a surgical R0 resection 4. Age > 18 years 5. 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< 1.5 7. Patients must sign and date a written independent Ethics Committee approved informed consent form
Exclusion criteria
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. 3. 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). 4. Concomitant treatment with any other experimental drug under investigation. 5. 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). 6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone. 7. 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. 8. Pregnancy 9. Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed 10. Indication for anticoagulant treatment. 11. Any contraindication listed in the labeling of nadroparin. 12. Documented history of heparin-induced thrombocytopenia with UFH or LMWH 13. 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. | — |
Contacts
Public ContactD. Storm
The Netherlands Cancer center NVALT Trial Desk Plesmanlaan 121
Outcome results
None listed