Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

NCT ID: NCT01891318

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-03
• Study Completion Date: 2025-12-31

Brief Summary

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)

II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.

II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.

III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.

OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.

The following outcomes were removed from the protocol in an amendment:

• Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) & Trailmaking Test B, and Trailmaking Test A
• QOL measured by FACT-BR and EORTC-QLQ30

Conditions

Tumors Metastatic to Brain

Study Design

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

Study Groups

Treatment (radiosurgery, surgery)

Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.

Group Type: EXPERIMENTAL

radiosurgery

Intervention Type: RADIATION

Undergo radiosurgery

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgical resection

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

Interventions

radiosurgery

Undergo radiosurgery

Intervention Type: RADIATION

therapeutic conventional surgery

Undergo surgical resection

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

Other Intervention Names

radiation surgery; quality of life assessment

Eligibility Criteria

Inclusion Criteria

• Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
• Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
• Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
• Patient must have a Karnofsky performance score of ≥ 70

Exclusion Criteria

• Patient deemed medically unfit to undergo surgical resection of brain metastasis
• Prior whole brain radiotherapy
• Patient with contraindication for imaging with MRI
• Inability to participate in study activities due to physical or mental limitations
• Inability or unwillingness to return for all the required follow-up visits
• At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
• Tumor located in the brainstem
• Imaging or cytologic evidence of leptomeningeal disease

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

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: WITHDRAWN

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Murphy, MD

Role: CONTACT

TaussigResearch@ccf.org

1-866-223-8100

Facility Contacts

Erin Murphy, MD

Role: primary

TaussigResearch@ccf.org

866-223-8100

Other Identifiers

CASE7312

Identifier Type: -

Identifier Source: org_study_id