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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

Tracking Information
First Submitted Date  ICMJE July 14, 2020
First Posted Date  ICMJE July 17, 2020
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE September 27, 2021
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
Local Control [ Time Frame: This will be assessed at 12 months ]
To compare local control (in months) of pre-operative versus post-operative SRS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
  • 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
  • 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
  • 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
  • Overall Survival [ Time Frame: This will be assessed at 6,12 and 24 months. ]
    Overall survival will be compared between both treatment arms
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre- Versus Post-operative SRS for Resectable Brain Metastases
Official Title  ICMJE A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Surgical Resection followed by SRS (Non-Experimental)
    Surgical Resection followed by SRS within 3 weeks of surgery date.
    Interventions:
    • Procedure: Brain Surgery
    • Radiation: Stereotactic Radiosurgery
  • Experimental: SRS followed by Surgical Resection (Experimental)
    SRS followed by surgery within 1 week of radiotherapy end date.
    Interventions:
    • Procedure: Brain Surgery
    • Radiation: Stereotactic Radiosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2020)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2026
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04474925
Other Study ID Numbers  ICMJE IIT-0010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AHS Cancer Control Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AHS Cancer Control Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AHS Cancer Control Alberta
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP