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| Name | Class |
|---|---|
| GT Medical Technologies, Inc. | INDUSTRY |
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The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resection without brachytherapy | Active Comparator | Patients will undergo craniotomy. |
|
| Resection plus brachytherapy | Experimental | Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Craniotomy | Procedure | Craniotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| freedom from local progression | With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. | 9 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| wound complications | Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criterion:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Moss, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Florida | Miami | Florida | 33143 | United States | ||
| Memorial Sloan Kettering at Basking Ridge (Consent Only) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Prospective randomized phase II multicenter trial.
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Patient will be blinded to their treatment until postoperatively.
| Cesium-131 brachytherapy | Radiation | Intracavitary Cesium-131 brachytherapy |
|
| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Memorial Sloan Kettering Monmouth (Consent Only) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Commack (Consent Only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003399 | Craniotomy |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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