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Dose Escalation Trial of Fractionated Stereotactic Radiosurgery for Brain Metastasis Greater Than 3cm

Phase 1
18 Years
Open (Enrolling)
Metastatic Malignant Neoplasm to Brain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Dose Escalation Trial of Fractionated Stereotactic Radiosurgery for Brain Metastasis Greater Than 3cm


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:


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:


Principal Investigator

Ian Crocker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Food and Drug Administration

Study ID:




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



Emory UniversityAtlanta, Georgia  30322