Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases

NCT04545814 | Completed Results DMC FDA Device

• 1 other identifier: PRO00038835
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center pilot study in which 10 patients with one to four brain metastases diagnosed on brain magnetic resonance imaging (MRI) within the past 30 days will be evaluated for study eligibility and enrolled as appropriate.

Conditions

Brain Metastases

Keywords

brain metastases; Gamma Knife; Stereotactic Radiosurgery

Outcome Measures

Primary Outcomes (2)

• The Number of Subjects Undergoing Resection Following SRS.

  All subjects undergoing resection following SRS will be documented.

  10 days following SRS

• The Number of Subjects With no Identifiable Disease Following Resection.

  Identifiable disease will be determined by post-treatment MRI of the brain.

  20 months

Secondary Outcomes (5)

• The Number of Subjects Achieving CNS Progression-free Survival.

  6, 12 and 18 months

• The Number of Subjects Achieving Overall Survival.

  6, 12 and 18 months

• The Number of Subjects With Leptomeningeal Carcinomatosis Using Preoperative SRS.

  Two years

• The Number of Subjects With Radiation Necrosis.

  Two years

• The Number of Subjects Reporting a High Quality of Life.

  Every 3 months until two years; 3, 6, 9, 12, 15, and 18 months reported

Study Arms (1)

Stereotactic Radiosurgery

EXPERIMENTAL

SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.

Device: Stereotactic Radiosurgery; Procedure: Surgical Resection; Device: Magnetic Resonance Imaging

Interventions

Stereotactic Radiosurgery DEVICE

Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy

Also known as: SRS

Stereotactic Radiosurgery

Surgical Resection PROCEDURE

Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.

Stereotactic Radiosurgery

Magnetic Resonance Imaging DEVICE

Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).

Stereotactic Radiosurgery

Eligibility Criteria

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

You may qualify if:

• Voluntary written consent must be given before performance of any study related procedure that's is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Female or Male subject's ≥ 18 years old at the time of informed consent.
• Radiographically confirmed solid tumor brain metastases.
• Criteria for surgical resection of at least one metastasis per neurosurgeon discretion.
• Stereotactic radiosurgery candidate per radiation oncologist discretion.
• A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery.
• For known and unknown primary, diagnosis-specific graded prognostic assessment (ds-GPA) estimated median survival no less than 6 months.
• Surgical resection able to be performed within 1-10 days after radiosurgery.
• Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-vascular endothelial growth factor (anti-VEGF) therapy.
• Female subjects who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• i. Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last study Intervention (female and male condoms should not be used together), OR ii. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
• Male subjects, even if surgically sterilized (ie, status post-vasectomy), who:
• Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through 4 months after the last study Intervention (female and male condoms should not be used together), OR

You may not qualify if:

• Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection.
• Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with surveillance.
• Patients with more than 4 brain metastases on MRI Brain.
• Lesion to be resected is more than 5 cm in any dimension.
• Patients with leptomeningeal metastases documented by MRI or cerebrospinal fluid (CSF) evaluation.
• Previous whole brain radiation therapy.
• Previous radiation therapy to the lesion to be resected.
• Planned adjuvant focal therapy including additional radiation therapy to the brain.
• Not a surgical candidate per neurosurgeon discretion.
• Not a stereotactic radiosurgery candidate per radiation oncologist discretion.
• Surgery unable to be performed between 1 - 10 days after radiosurgery.
• Women who are pregnant or nursing as treatment involves unforeseeable risks to the fetus or child.
• Patients who have a known or unknown primary and have an estimated median survival of less than 6 months per ds-GPA.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Asher AL, Burri SH, Wiggins WF, Kelly RP, Boltes MO, Mehrlich M, Norton HJ, Fraser RW. A new treatment paradigm: neoadjuvant radiosurgery before surgical resection of brain metastases with analysis of local tumor recurrence. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):899-906. doi: 10.1016/j.ijrobp.2013.12.013.

  PMID: 24606851 BACKGROUND

• Patel KR, Burri SH, Asher AL, Crocker IR, Fraser RW, Zhang C, Chen Z, Kandula S, Zhong J, Press RH, Olson JJ, Oyesiku NM, Wait SD, Curran WJ, Shu HK, Prabhu RS. Comparing Preoperative With Postoperative Stereotactic Radiosurgery for Resectable Brain Metastases: A Multi-institutional Analysis. Neurosurgery. 2016 Aug;79(2):279-85. doi: 10.1227/NEU.0000000000001096.

  PMID: 26528673 BACKGROUND

• Huff WX, Agrawal N, Shapiro S, Miller J, Kulwin C, Shah M, Savage JJ, Payner T, Vortmeyer A, Watson G, Dey M. Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases: study protocol for a phase II trial. Radiat Oncol. 2018 Dec 20;13(1):252. doi: 10.1186/s13014-018-1178-8.

  PMID: 30572923 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery; Magnetic Resonance Imaging

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; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Michael Straza, MD
• Organization: Medical College of Wisconsin

mstraza@mcw.edu

805-4451

Study Officials

• Michael Straza, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: January 15, 2021
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)