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

NCT01891318 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: CASE7312
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Tumors Metastatic to Brain

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)

  Day 0

• Proportion of participants without local failure (Phase II)

  Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.

  Up to 3 years

Secondary Outcomes (3)

• Proportion of participants with distant brain failure

  Up to 3 years

• Rate of radiation necrosis/steroid dependency

  Up to 3 years

• Rate of salvage treatment

  Up to 3 years

Study Arms (1)

Treatment (radiosurgery, surgery)

EXPERIMENTAL

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

Radiation: radiosurgery; Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment

Interventions

radiosurgery RADIATION

Undergo radiosurgery

Also known as: radiation surgery

Treatment (radiosurgery, surgery)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Treatment (radiosurgery, surgery)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (radiosurgery, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

WITHDRAWN

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Erin Murphy, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Murphy, MD

CONTACT

1-866-223-8100; TaussigResearch@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 3, 2013
• Study Start: July 3, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

US (2)