Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
| Status: | Suspended |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | September 2012 |
| End Date: | July 2022 |
Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis
This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in
treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays
directly to the tumor and cause less damage to normal tissue. Giving fractionated
stereotactic radiosurgery may kill more tumor cells.
treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays
directly to the tumor and cause less damage to normal tissue. Giving fractionated
stereotactic radiosurgery may kill more tumor cells.
PRIMARY OBJECTIVE:
To demonstrate the safety and feasibility of treating brain metastases or resection cavities
greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated
radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions
per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions
total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3
months thereafter.
To demonstrate the safety and feasibility of treating brain metastases or resection cavities
greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated
radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions
per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions
total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3
months thereafter.
Inclusion Criteria:
- Pathologic proven diagnosis of solid tumor malignancy
- Solitary brain metastasis or brain metastasis resection cavity with maximal diameter ≥
3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.)
- Mini Mental Status Exam (MMSE) ≥ 18 prior to study entry
- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥
70%
Exclusion Criteria:
- Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target
volume would have received more than 12 Gy
- RPA class III (KPS < 70%)
- Brain metastasis or resection cavity volume < 3 cm or > 6 cm
- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors,
leukemias, or lymphomas) or unknown tumor histologies
- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
- Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or
cerebrospinal fluid (CSF) cytology
- Current pregnancy
- More than 8 weeks between resection and radiosurgical procedure
- Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic
apparatus (optic nerves and chiasm)
- Inability to undergo MRI evaluation for treatment planning and follow-up
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