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Pre- Versus Post-operative SRS for Resectable Brain Metastases

Primary Purpose

Brain Metastases

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Brain Surgery
Stereotactic Radiosurgery
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Neurosurgery, Stereotactic Radiosurgery

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer CentreRecruiting
  • Cross Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgical Resection followed by SRS (Non-Experimental)

SRS followed by Surgical Resection (Experimental)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local Control
To compare local control (in months) of pre-operative versus post-operative SRS
Distant Brain Recurrence Rate
To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS
Leptomeningeal Recurrence Rate
To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS
Overall Survival
Overall survival will be compared between both treatment arms
Hopkins Verbal Learning Test
Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index.
Controlled Oral Word Association
Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe.
Trial Making Tests
Participants are scored on their ability to complete the test within a certain timeframe.

Full Information

First Posted
July 14, 2020
Last Updated
January 17, 2023
Sponsor
AHS Cancer Control Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04474925
Brief Title
Pre- Versus Post-operative SRS for Resectable Brain Metastases
Official Title
A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Neurosurgery, Stereotactic Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Resection followed by SRS (Non-Experimental)
Arm Type
Active Comparator
Arm Description
Surgical Resection followed by SRS within 3 weeks of surgery date.
Arm Title
SRS followed by Surgical Resection (Experimental)
Arm Type
Experimental
Arm Description
SRS followed by surgery within 1 week of radiotherapy end date.
Intervention Type
Procedure
Intervention Name(s)
Brain Surgery
Intervention Description
Surgery to remove brain metastases
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Other Intervention Name(s)
SRS
Intervention Description
SRS uses many focused radiation beams to treat tumors within the brain
Primary Outcome Measure Information:
Title
Local Control
Description
To compare local control (in months) of pre-operative versus post-operative SRS
Time Frame
This will be assessed at 12 months
Secondary Outcome Measure Information:
Title
Local Control
Description
To compare local control (in months) of pre-operative versus post-operative SRS
Time Frame
This will be assessed at 6 and 24 months.
Title
Distant Brain Recurrence Rate
Description
To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS
Time Frame
This will be assessed at 6,12 and 24 months.
Title
Leptomeningeal Recurrence Rate
Description
To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS
Time Frame
This will be assessed at 6,12 and 24 months.
Title
Overall Survival
Description
Overall survival will be compared between both treatment arms
Time Frame
This will be assessed at 6,12 and 24 months.
Title
Hopkins Verbal Learning Test
Description
Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index.
Time Frame
This will be assessed at 3,6,9,12,16 and 24 months.
Title
Controlled Oral Word Association
Description
Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe.
Time Frame
This will be assessed at 3,6,9,12,16 and 24 months.
Title
Trial Making Tests
Description
Participants are scored on their ability to complete the test within a certain timeframe.
Time Frame
This will be assessed at 3,6,9,12,16 and 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Faruqi, MD
Phone
403-521-3620
Email
Muhammad.Faruqi@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Huhammad Faruqi, MD
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Patel, MD
Phone
780-432-8518
Email
samir.patel2@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Samir Patel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre- Versus Post-operative SRS for Resectable Brain Metastases

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