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

Memorial Sloan Kettering Cancer Center7 个研究点分布在 1 个国家目标入组 103 人2020年12月24日

适应症Recurrent Brain Metastases

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Recurrent Brain Metastases
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 103
试验地点: 7
主要终点: freedom from local progression
状态: 招募中
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2020年12月24日

结束日期

2026年12月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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.

结局指标

主要结局

freedom from local progression

时间窗: 9 months following surgery

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.