|
|
|
|
|
|
Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Pfizer |
Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00135876 |
In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.
Condition | Intervention | Phase |
Venous Thromboembolism Brain Tumors |
Drug: dalteparin |
Phase III |
MedlinePlus related topics: | Brain Cancer Cancer |
ChemIDplus related topics: | Heparin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE) |
Estimated Enrollment: | 512 |
Study Start Date: | October 2002 |
Study Completion Date: | November 2006 |
Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Both of the following criteria must be satisfied:
Exclusion Criteria:
If one or more of the following criteria are satisfied, the patient is not eligible for the study:
United States, Illinois | |||||
Kellogg Cancer Center - Evanston Northwestern Healthcare | |||||
Evanston, Illinois, United States, 60201 | |||||
United States, Michigan | |||||
Henry Ford Hospital | |||||
Detroit, Michigan, United States, 48202 | |||||
United States, Utah | |||||
Huntsman Cancer Institute | |||||
Salt Lake City, Utah, United States, 84112-5550 | |||||
Australia, New South Wales | |||||
The St. George Hospital | |||||
Kogarah, New South Wales, Australia, 2217 | |||||
Australia, Western Australia | |||||
Royal Perth Hospital | |||||
Perth, Western Australia, Australia, 6847 | |||||
Sir Charles Gairdner Hospital | |||||
Nedlands, Western Australia, Australia, 6009 | |||||
Canada, Alberta | |||||
Cross Cancer Institute | |||||
Edmonton, Alberta, Canada, T6G 1Z2 | |||||
Canada, Manitoba | |||||
CancerCare Manitoba | |||||
Winnipeg, Manitoba, Canada, R3E 0V9 | |||||
Canada, Nova Scotia | |||||
Nova Scotia Cancer Centre | |||||
Halifax, Nova Scotia, Canada, B3H 1V7 | |||||
Canada, Ontario | |||||
Toronto-Sunnybrook Regional Cancer Centre | |||||
Toronto, Ontario, Canada, M4N 3M5 | |||||
Princess Margaret Hospital | |||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
The Ottawa Hospital Regional Cancer Centre | |||||
Ottawa, Ontario, Canada, K1H 8L6 | |||||
Italy | |||||
Ospedali Riuniti di Bergamo | |||||
Bergamo, Italy, 24128 | |||||
Università di Perugia | |||||
Perugia, Italy, 06123 |
Ontario Clinical Oncology Group (OCOG) |
Pfizer |
Study Chair: | James Perry, MD | Toronto Sunnybrook Regional Cancer Centre |
Principal Investigator: | Mark Levine, MD | Ontario Clinical Oncology Group |
Principal Investigator: | William Geerts, MD | Toronto Sunnybrook Regional Cancer Centre |
Principal Investigator: | Jim Julian, MMath | McMaster University, Dept of Clinical Epidemiology & Biostatistics |
Study ID Numbers: | 524E-CVD-0056-013 |
First Received: | August 24, 2005 |
Last Updated: | April 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00135876 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
|
|
|
|
|