Pre- Versus Post-operative SRS for Resectable Brain Metastases

NCT ID: NCT04474925

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2025-04-07

Brief Summary

The purpose of this study is to determine if performing radiotherapy (SRS) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases.

Brain metastases occur when cancer cells from a primary cancer (e.g. lung, breast, colon) travel through the bloodstream and spread (metastasize) to the brain. As these new tumors grow they apply pressure and change how healthy brain tissue works. This can lead to a loss of brain function and worsening quality of life. Treatments for patients whose cancer has spread to the brain is often surgery, radiation therapy (radiotherapy) or a combination of both.

Surgery is one the main treatments for brain tumors. To remove the tumor, a neurosurgeon makes an opening in the skull and attempts to the remove the entire tumor. If the tumor is too close to important brain tissue, the surgeon may attempt to remove part of the tumor. Removal of the tumor from the brain tissue is called resection. The complete or partial removal of tumor helps to relieve symptoms by reducing pressure on healthy tissues and reduces the amount of tumor that needs to be treated by radiotherapy.

One type of radiotherapy used to treat brain metastases is stereotactic radiosurgery (SRS). SRS uses many focused radiation beams to treat tumors within the brain. Unlike surgery, there is no incision or cut being made. Instead, SRS uses an accurate map of your brain to deliver a precise beam of radiation to the tumors. The radiation damages the tumor cells forcing them to shrink and die off. The focused radiation beams also limit damage to healthy brain tissue minimizing side effects.

Surgery followed by radiotherapy is a standard treatment for brain metastases. However, there are still risks associated with the combination of treatments. This study plans to investigate whether performing surgery prior to SRS results in improved quality of life and decreased side effects.

Conditions

Brain Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical Resection followed by SRS (Non-Experimental)

Surgical Resection followed by SRS within 3 weeks of surgery date.

Group Type: ACTIVE_COMPARATOR

Brain Surgery

Intervention Type: PROCEDURE

Surgery to remove brain metastases

Stereotactic Radiosurgery

Intervention Type: RADIATION

SRS uses many focused radiation beams to treat tumors within the brain

SRS followed by Surgical Resection (Experimental)

SRS followed by surgery within 1 week of radiotherapy end date.

Group Type: EXPERIMENTAL

Brain Surgery

Intervention Type: PROCEDURE

Surgery to remove brain metastases

Stereotactic Radiosurgery

Intervention Type: RADIATION

SRS uses many focused radiation beams to treat tumors within the brain

Interventions

Brain Surgery

Surgery to remove brain metastases

Intervention Type: PROCEDURE

Stereotactic Radiosurgery

SRS uses many focused radiation beams to treat tumors within the brain

Intervention Type: RADIATION

Other Intervention Names

SRS

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Pathologically-proven primary malignancy
• ECOG 0-2
• Ability to complete neurocognitive testing without assistance from family or friends.
• Previous SRS to lesions other than the one being resected is allowed
• Patients of childbearing / reproductive potential must have a negative urine or serum pregnancy test ≤7 days before enrollment
• Participants capable of giving informed consent, or if appropriate participants having an acceptable individual capable of giving consent

Exclusion Criteria

• Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual
• Patients unable to undergo MRI scan (e.g. pacemaker)
• Leptomeningeal disease
• Germ cell tumor, small cell lung cancer or hematological primary malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Countries

Canada

References

Das S, Faruqi S, Nordal R, Starreveld Y, Kelly J, Bowden G, Amanie J, Fairchild A, Lim G, Loewen S, Rowe L, Wallace C, Ghosh S, Patel S. A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases. BMC Cancer. 2022 Dec 30;22(1):1368. doi: 10.1186/s12885-022-10480-z.

Reference Type: DERIVED

PMID: 36585629 (View on PubMed)

Other Identifiers

IIT-0010

Identifier Type: -

Identifier Source: org_study_id