NCT00718354.
Study name | Randomized, phase III‐b, multi‐centre, open‐label, parallel study of enoxaparin (low molecular weight heparin) given concomitantly with chemotherapy vs chemotherapy alone in patients with inoperable gastric and gastro‐oesophageal cancer |
Methods | Randomised, open‐label, multicentre study. Methods of randomisation and allocation concealment unclear |
Participants | Patients with inoperable (locally advanced) or metastatic newly diagnosed gastric or gastro‐oesophageal cancer |
Interventions | Intervention: LMWH, enoxaparin (1 mg/kg SC once daily) in addition to standard chemotherapy up to 6 months Control: standard chemotherapy (up to 6 cycles) |
Outcomes | Primary outcome: event‐free survival (composite endpoint of overall survival plus free of symptomatic VTE) Secondary outcomes: incidence of symptomatic VTE, overall survival, major and minor bleeding during chemotherapy or up to 30 days after last dose is provided, serious adverse events, all reported adverse events, HIT |
Starting date | July 2008 |
Contact information | Maganji JM, mmaganji@tri‐london.ac.uk |
Notes |
NCT00718354 Study status in ClinicalTrials.gov is "complete." |