Status:
UNKNOWN
Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases
Lead Sponsor:
Good Samaritan Hospital Medical Center, New York
Conditions:
Metastatic Brain Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to ...
Detailed Description
SCHEMA For Patients with MRI Evidence of Brain Metastasis within 1 Month Prior to Registration Prior to Treatment Start Confirmation of patient's insurance coverage prior to receiving study-related p...
Eligibility Criteria
Inclusion
- ELIGIBILITY CHECKLIST
- Evidence of at least one brain metastasis on a gadolinium contrast-enhanced MRI
- Pathologic/histological/cytologic proof of a diagnosis of a non-hematopoietic malignancy within 5 years of study entry.
- Patient ≥18 years of age?
- Fall into RTOG Recursive Partition Analysis (RPA) class I or II.
- Karnofsky Performance Score ≥70. (See Appendix III)
- Biopsy done at least 1 week prior to registration. (This requirement does not apply to stereotactic biopsies.)
Exclusion
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia.
- Creatinine level \> 1.4 mg/dl drawn ≤30 days prior to study entry.
- Severe, active co-morbitities.
- Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Uncontrolled, clinically significant cardiac arrhythmias
- Pregnancy
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01890278
Start Date
June 1 2013
End Date
March 1 2017
Last Update
July 1 2013
Active Locations (1)
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1
Good Samaritan Hospital Medical Center
West Islip, New York, United States, 11795