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Pre- Versus Post-operative SRS for Resectable Brain Metastases

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ClinicalTrials.gov Identifier: NCT04474925
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.


Condition or disease Intervention/treatment Phase
Brain Metastases Procedure: Brain Surgery Radiation: Stereotactic Radiosurgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : August 1, 2026

Arm Intervention/treatment
Active Comparator: Surgical Resection followed by SRS (Non-Experimental)
Surgical Resection followed by SRS within 3 weeks of surgery date.
Procedure: Brain Surgery
Surgery to remove brain metastases

Radiation: Stereotactic Radiosurgery
SRS uses many focused radiation beams to treat tumors within the brain
Other Name: SRS

Experimental: SRS followed by Surgical Resection (Experimental)
SRS followed by surgery within 1 week of radiotherapy end date.
Procedure: Brain Surgery
Surgery to remove brain metastases

Radiation: Stereotactic Radiosurgery
SRS uses many focused radiation beams to treat tumors within the brain
Other Name: SRS




Primary Outcome Measures :
  1. Local Control [ Time Frame: This will be assessed at 12 months ]
    To compare local control (in months) of pre-operative versus post-operative SRS


Secondary Outcome Measures :
  1. Local Control [ Time Frame: This will be assessed at 6 and 24 months. ]
    To compare local control (in months) of pre-operative versus post-operative SRS

  2. Distant Brain Recurrence Rate [ Time Frame: This will be assessed at 6,12 and 24 months. ]
    To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS

  3. Leptomeningeal Recurrence Rate [ Time Frame: This will be assessed at 6,12 and 24 months. ]
    To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS

  4. Overall Survival [ Time Frame: This will be assessed at 6,12 and 24 months. ]
    Overall survival will be compared between both treatment arms

  5. Hopkins Verbal Learning Test [ Time Frame: This will be assessed at 3,6,9,12,16 and 24 months. ]
    Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index.

  6. Controlled Oral Word Association [ Time Frame: This will be assessed at 3,6,9,12,16 and 24 months. ]
    Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe.

  7. Trial Making Tests [ Time Frame: This will be assessed at 3,6,9,12,16 and 24 months. ]
    Participants are scored on their ability to complete the test within a certain timeframe.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474925


Locations
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Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Muhammad Faruqi, MD    403-521-3620    Muhammad.Faruqi@albertahealthservices.ca   
Principal Investigator: Huhammad Faruqi, MD         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Samir Patel, MD    780-432-8518    samir.patel2@albertahealthservices.ca   
Principal Investigator: Samir Patel, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04474925    
Other Study ID Numbers: IIT-0010
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AHS Cancer Control Alberta:
Neurosurgery
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases