Randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small cell lung cancer patients: The NVALT-8 study.

8506Background: aCT improves overall survival in pts with completely resected stage II/ III NSCLC. LMWH may also improve survival. We hypothesized that in pts with completely resected NSCLC adding nadroparin (nadro) to aCT will improve recurrence-free survival (RFS). This effect may be different in high/low (SUVmax ≥ 10 vs < 10) FDG avidity NSCLC. Methods: Prospective multicenter phase III study in pts with resectable NSCLC who were randomized within 4-6 wks after surgery to nadro sc daily for 16 wks or no nadro (controle). All pts received 4 cycles pemetrexed (500 mg/m2) for non-squamous or gemcitabine 1000 mg/m2 for squamous histologies and cisplatin (75 mg/m2) on day 1 every 3 wks. Other inclusion criteria: PS 0-2, adequate organ function, INR<1.5. Exclusion criteria: R1 and wedge/segmental resection, prior chemo- or radiotherapy or contra-indication for nadro. Primary endpoint is RFS. Slow accrual enabled to decrease the number of pts from 600 to 202, still providing 80% power to compare RFS at 94 eve...