Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- freedom from local progression
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patient will be blinded to their treatment until postoperatively.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Resection without brachytherapy
Patients will undergo craniotomy.
干预措施: Craniotomy (Procedure)
Resection plus brachytherapy
Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
干预措施: Craniotomy (Procedure)
Resection plus brachytherapy
Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
干预措施: Cesium-131 brachytherapy (Radiation)
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.
次要结局
- wound complications(3 months)