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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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


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