Fractionated Stereotactic Radiosurgery for Large Brain Metastases

NCT ID: NCT02054689

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-16
• Study Completion Date: 2023-03-09

Brief Summary

This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.

Conditions

Large Brain Mets

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractionated Stereotactic Radiosurgery

24 to 36 Gy in 3 fractions (8-12 Gy/fx).

Group Type: OTHER

Fractionated Stereotactic Radiosurgery

Intervention Type: RADIATION

SRS SBRT CyberKnife Trilogy True Beam Radiosurgery

Interventions

Fractionated Stereotactic Radiosurgery

SRS SBRT CyberKnife Trilogy True Beam Radiosurgery

Intervention Type: RADIATION

Other Intervention Names

SRS; SBRT; CyberKnife; Trilogy; True Beam; Radiosurgery

Eligibility Criteria

Inclusion Criteria

• Male or female patients ≥ 18 years of age
• A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
• The target lesion(s) can be accurately measured in at least one dimension according to RECIST
• No prior radiotherapy to the brain
• Previous or concurrent systemic or targeted chemotherapy is allowed
• Patients must have an extra-cranial primary tumor diagnosis
• Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
• The additional lesions will each be treated with single fraction stereotactic radiosurgery
• Patient may be on steroids or anti-epileptics
• Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
• Patients do not need a histologically proven diagnosis of brain mets

Exclusion Criteria

• Symptomatic patients in need of surgery to the "target" lesion
• Four or more newly-diagnosed lesions
• Prior surgical resection of targeted tumor
• Prior WBRT
• Primary brain tumor
• Pregnant or breast-feeding patients
• Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven Burton

OTHER

Sponsor Role: lead

Responsible Party

Steven Burton

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steve Burton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCC 11-091

Identifier Type: -

Identifier Source: org_study_id