Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.

Status: Terminated
Location: See location...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• DISEASE CHARACTERISTICS:

• Diagnosis of brain metastases from an extracranial primary site

• Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI

• Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology

• Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)

• RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:

• RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease

• RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease

• No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex

• No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)

• No radiographic or cytologic evidence of leptomeningeal disease

• PATIENT CHARACTERISTICS:

• See Disease Characteristics

• Not pregnant or nursing

• Negative pregnancy test

• No concurrent uncontrolled illness including, but not limited to, any of the following:

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Psychiatric illness

• No contraindication to SRS, whole-brain radiotherapy, or MRI

• PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior brain surgery other than resection of metastasis

• No prior brain radiotherapy

Locations
United States
North Carolina
Duke University Medical Center
Durham
Time Frame
Start Date: October 2008
Completion Date: August 2010
Participants
Target number of participants: 6
Treatments
Experimental: Pre-Operative SRS
SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Duke University

This content was sourced from clinicaltrials.gov

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