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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Resection followed by SRS (Non-Experimental) | Active Comparator | Surgical Resection followed by SRS within 3 weeks of surgery date. |
|
| SRS followed by Surgical Resection (Experimental) | Experimental | SRS followed by surgery within 1 week of radiotherapy end date. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Surgery | Procedure | Surgery to remove brain metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | To compare local control (in months) of pre-operative versus post-operative SRS | This will be assessed at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | To compare local control (in months) of pre-operative versus post-operative SRS | This will be assessed at 6 and 24 months. |
| Distant Brain Recurrence Rate | To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36585629 | Derived | 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. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic Radiosurgery | Radiation | SRS uses many focused radiation beams to treat tumors within the brain |
|
|
| This will be assessed at 6,12 and 24 months. |
| Leptomeningeal Recurrence Rate | To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS | This will be assessed at 6,12 and 24 months. |
| Overall Survival | Overall survival will be compared between both treatment arms | This will be assessed at 6,12 and 24 months. |
| Hopkins Verbal Learning Test | Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. | This will be assessed at 3,6,9,12,16 and 24 months. |
| Controlled Oral Word Association | Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe. | This will be assessed at 3,6,9,12,16 and 24 months. |
| Trial Making Tests | Participants are scored on their ability to complete the test within a certain timeframe. | This will be assessed at 3,6,9,12,16 and 24 months. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |