Overall Survival of Inoperable Gastric/GastroOesophageal Cancer Subjects on Treating With LMWH + Chemotherapy(CT) vs Standard CT
NCT00718354 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 740
Last updated 2015-05-13
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.
Conditions
Interventions
- DRUG
-
Enoxaparin
Once daily dose of 1mg/Kg of body weight for 6 months
- DRUG
-
Standard Chemotherapy
Investigator's discretion
Sponsors & Collaborators
-
Thrombosis Research Institute
lead OTHER
Principal Investigators
-
Ajay K Kakkar, PhD · Thrombosis Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-08-31
Countries
- India
Study Locations
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