Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Metastatic Malignant Neoplasm to Brain - Unspecified Adult Solid Tumor, Protocol Specific
Conditions: official terms
Brain Neoplasms - Neoplasms - Neoplasms, Second Primary
Conditions: Keywords
Brain metastasis
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Hypofractionated Radiosurgery
Type: Radiation
Overall Status
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
Detailed Description

I. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 to 14 days after completion 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

- No 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
Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Ian R. Crocker, MD - 404-778-4731 - icrocke@emory.edu
Start Date
September 2012
Emory University
Emory University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page