Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00028678
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
- Detailed Description
OBJECTIVES:
* Determine whether dalteparin, initiated at the time of conventional radiotherapy, improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme.
* Determine the time to progression in patients treated with this regimen.
* Determine the incidence of thromboembolic events in patients treated with this regimen.
* Determine the feasibility and toxicity of dalteparin in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo cranial irradiation 5 days a week for 7 weeks. Beginning concurrently with initiation of radiotherapy, patients receive dalteparin subcutaneously once daily for up to 2 years in the absence of unacceptable toxicity. Patients may continue receiving dalteparin after year 2 at the discretion of the investigator.
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Scroll for more (2 remaining)H. Lee Moffitt Cancer Center and Research Institute🇺🇸Tampa, Florida, United States