Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study.

ABSTRACT:

Background

Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.

Methods

Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).

Results

Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two grou

SUBMITTER: Groen HJM 

PROVIDER: S-EPMC6738047 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature