A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

NCT05341739 | Active Not Recruiting DMC

• 1 other identifier: 2021-240-AGH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.

Conditions

Brain Metastases, Adult

Keywords

Stereotactic Radiosurgery (SRS)

Outcome Measures

Primary Outcomes (1)

• Radiographic Local Control

  Radiographic local control at 1 year following completion of pre-operative SRS followed by surgical resection of brain metastasis. Local control will be according to the Response Assessment criteria for Neuro-Oncology (RANO) for brain metastases.

  4-5 Years from first subject enrolled.

Secondary Outcomes (3)

• Leptomeningeal disease

  4-5 years from first subject enrolled.

• Radio-Necrosis

  4-5 years from first subject enrolled

• Pseudo-Progression

  4-5 years from first subject enrolled

Study Arms (1)

Pre-Operative Stereotactic Radiosurgery (SRS)

EXPERIMENTAL

Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.

Other: Pre-operative Stereotactic Radiosurgery

Interventions

Pre-operative Stereotactic Radiosurgery OTHER

Pre-operative SRS will be performed prior to the surgical resection of the brain metastases.

Pre-Operative Stereotactic Radiosurgery (SRS)

Eligibility Criteria

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

You may qualify if:

• Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site
• Solid tumor brain metastases
• Age≥ 18 years
• Karnofsky Performance Status ≥70
• Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis
• Maximum tumor diameter of index lesions \<5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection)
• Brain MRI within 1 month of initiation of brain SRS
• No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases
• Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
• Patient must have the ability to understand and the willingness to sign a written informed consent document
• All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
• Patients receiving prior SRS for brain metastases in other locations of the brain are eligible
• Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated

You may not qualify if:

• Prior WBRT or SRS to the index lesion
• Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter
• Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits.
• Karnofsky Performance Status (KPS) less than (\<)70.
• Patients with absolute contraindication to MRI imaging are not eligible for the study
• Patients who are pregnant are excluded from the study.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Elekta Limited: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rodney E Wegner, MD

  AHN Radiation Oncology

  PRINCIPAL INVESTIGATOR

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: Radiation Oncologist

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: December 14, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)