Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Study Overview
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Brief Summary
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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.

Official Title
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Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Conditions
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Recurrent Brain Metastases

Intervention / Treatment
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* Procedure: Craniotomy
* Radiation: Cesium-131 brachytherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 18 years of age who are capable of giving consent Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (>/=95%) resection Karnofsky Performance Status score (KPS) of ≥70 Ability to undergo brain MRI with gadolinium Exclusion Criteria: Unable to tolerate MRI or CT imaging Pregnancy (patients must have a negative pregnancy test within 30 days of the operation) Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable) Diagnosis of leptomeningeal carcinomatosis or >5 additional active or untreated CNS lesions for a total of >6 active lesions Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2 Apposition of tumor margin to brainstem or optic apparatus Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency Urgent surgery required prior to availability of brachytherapy Intraoperative Exclusion Criterion: Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized phase II multicenter trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resection without brachytherapy<br>Patients will undergo craniotomy. | Procedure: Craniotomy<br>* Craniotomy<br>|
| Experimental: Resection plus brachytherapy<br>Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist. | Procedure: Craniotomy<br>* Craniotomy<br>Radiation: Cesium-131 brachytherapy<br>* Intracavitary Cesium-131 brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cs-131 Brachytherapy, Brain Metastasis, 20-542