Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Conditions
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
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hypofractionated Radiosurgery
Type: Radiation
Overall Status
Recruiting
Summary
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
PRIMARY OBJECTIVES:

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
Location
Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Ian R. Crocker, MD - 404-778-4731 - icrocke@emory.edu
Start Date
September 2012
Sponsors
Emory University
Source
Emory University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page