Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2004 |
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
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.
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.
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.
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.
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
We found this trial at
1
site
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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