Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

NCT ID: NCT02514915

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2021-07-22

Brief Summary

The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Detailed Description

Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.

Conditions

Malignant Neoplasm Brain

Study Design

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

Study Groups

Stereotactic Radiosurgery

Subjects will receive stereotactic radiosurgery prior to resection

Group Type: OTHER

Stereotactic Radiosurgery

Intervention Type: RADIATION

Radiation therapy

Interventions

Stereotactic Radiosurgery

Radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Life expectancy of at least 12 weeks
• Karnofsky performance status of at least 50
• No contraindications to MRI scanning with intravenous contrast.
• MRI scan consistent with brain metastasis as per radiology report.
• Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
• Patients must have an extra-cranial primary tumor diagnosis.
• Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
• Additional lesions will each be treated with stereotactic radiosurgery.
• Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
• 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

Exclusion Criteria

• Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
• Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
• More than four additional diagnosed brain metastases.
• Contraindication to general anesthesia.
• Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
• Primary brain tumor.
• Contraindication to MRI scans or intravenous contrast.
• Pregnant and breast-feeding females.

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

Sponsors

Christopher Wilke

OTHER

Sponsor Role: lead

Responsible Party

Christopher Wilke

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher A Wilke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Shadyside Radiation Oncology Department

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCC 14-150

Identifier Type: -

Identifier Source: org_study_id