Dose Escalation Trial of Fractionated Stereotactic Radiosurgery for Brain Metastasis Greater Than 3cm
18 Years
N/A
Both
Metastatic Malignant Neoplasm to Brain, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Dose Escalation Trial of Fractionated Stereotactic Radiosurgery for Brain Metastasis Greater Than 3cm
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.
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
- Mini Mental Status Exam (MMSE) >= 18 prior to study entry
- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status >= 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 (Karnofsky Performance status [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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of >= 3 develops in =< 2 of 6 patients in a dose group
Outcome Description:
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Outcome Time Frame:
4 months
Safety Issue:
Yes
Principal Investigator
Ian Crocker
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emory University
Authority:
United States: Food and Drug Administration
Study ID:
RAD2156-11
NCT ID:
NCT01705548
Start Date:
September 2012
Completion Date:
Related Keywords:
- Metastatic Malignant Neoplasm to Brain
- Unspecified Adult Solid Tumor, Protocol Specific
- Brain metastasis
- Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Emory University | Atlanta, Georgia 30322 |
