Metastatic Brain Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Conventional vs IMRT Whole Brain Radiotherapy for Brain Metastases
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 the parts of the brain that do not contain tumors is reduced. This study will look to see if this approach results in less hair loss or fewer memory Problems, as compared to the standard technique. The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
ELIGIBILITY CHECKLIST Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Good Samaritan Hospital Medical Center | West Islip | New York |
Lead Sponsor | Collaborator |
---|---|
Good Samaritan Hospital Medical Center, New York |
United States,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alopecia | 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 the parts of the brain that do not contain tumors is reduced. | 1 to 4 months after radiation | Yes |
Secondary | The study will also look at the effectiveness of both techniques in controlling the growth of the tumor. | IMRT is more expensive than conventional treatment therefor it is important to evaluation whether the newer technique improves quality of life. | 1 year | No |
Secondary | Quality of life | Quality of life as assessed by Mini-mental status examination and patient reported EORTC-BN20 instrument | 1 year after radiation | No |
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