Pre- Versus Post-operative SRS for Resectable Brain Metastases

NCT04474925 | Terminated Phase 3 DMC

• 1 other identifier: IIT-0010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Neurosurgery; Stereotactic Radiosurgery

Outcome Measures

Primary Outcomes (1)

• Local Control

  To compare local control (in months) of pre-operative versus post-operative SRS

  This will be assessed at 12 months

Secondary Outcomes (7)

• Local Control

  This will be assessed at 6 and 24 months.

• Distant Brain Recurrence Rate

  This will be assessed at 6,12 and 24 months.

• Leptomeningeal Recurrence Rate

  This will be assessed at 6,12 and 24 months.

• Overall Survival

  This will be assessed at 6,12 and 24 months.

• Hopkins Verbal Learning Test

  This will be assessed at 3,6,9,12,16 and 24 months.

Study Arms (2)

Surgical Resection followed by SRS (Non-Experimental)

ACTIVE COMPARATOR

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

Procedure: Brain Surgery; Radiation: Stereotactic Radiosurgery

SRS followed by Surgical Resection (Experimental)

EXPERIMENTAL

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

Procedure: Brain Surgery; Radiation: Stereotactic Radiosurgery

Interventions

Brain Surgery PROCEDURE

Surgery to remove brain metastases

SRS followed by Surgical Resection (Experimental); Surgical Resection followed by SRS (Non-Experimental)

Stereotactic Radiosurgery RADIATION

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

Also known as: SRS

SRS followed by Surgical Resection (Experimental); Surgical Resection followed by SRS (Non-Experimental)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

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

Calgary, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 36585629 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: September 27, 2021
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)