Metastatic Cancer
Conditions
Keywords
tumors metastatic to brain
Brief summary
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
Detailed description
OBJECTIVES: Primary * Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system. Secondary * Determine the survival of patients treated with this therapy. * Determine distant recurrence of disease in patients treated with this therapy. * Determine the toxicity of this therapy in these patients. * Determine the quality of life of patients treated with this therapy. OUTLINE: This is a nonrandomized study. Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system. Quality of life is assessed at baseline and then every 3 months for 2 years. Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.
Interventions
PROCEDUREconventional surgery
RADIATIONintraoperative radiation therapy
Sponsors
The Cleveland Clinic
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan * Resectable disease * Histological evidence of metastatic carcinoma by intraoperative pathology * No primary lymphoma, germ cell carcinoma, or small cell lung cancer PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No uncontrolled hypertension * No unstable angina pectoris * No uncontrolled dysrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious infection * No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis Endocrine therapy * Not specified Radiotherapy * No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery * No concurrent external beam radiotherapy to the brain * Not planning adjuvant whole brain radiotherapy after study therapy Surgery * Not specified Other * No other prior conventional or investigational local or systemic agents for brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate as measured by MRI with contrast at 1 year | — |
Countries
United States
Outcome results
None listed