CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 740 enrolled
Drug / intervention
Enoxaparin +1 moredrug
Likely dose
Enoxaparin 1mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00718354
NCT00718354Phase 3Completed

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

Thrombosis Research Institute·interventional·Posted Jul 18, 2008·Updated May 13, 2015

In Brief

A Phase 3 clinical trial evaluating Enoxaparin and Standard Chemotherapy for Gastric Cancer and Gastroesophageal Cancer. Completed, enrolled 740 participants across 15 sites.

Detailed Summary

Due to evidence available both in terms of efficacy and safety of low molecular weight heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing surgical intervention, and its extended use in higher doses for the prevention of recurrent thromboembolism in cancer patients with established thrombosis, with a view that the potential benefits for survival in cancer patients from low molecular weight heparin therapy comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose) for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2008
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.0 years ago

Interventions

Enoxaparindrug

Once daily dose of 1mg/Kg of body weight for 6 months

Standard Chemotherapydrug

Investigator's discretion