Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal
赞助:
Centre Francois Baclesse
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | March 2022 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)[ Time Frame: 6 months after end of Stereotactic radiation therapy ] Local tumoral response rate defined according to the recommendations of the RECIST criteria[ Time Frame: 6 months after end of Stereotactic radiation therapy ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal | ||
| 正式标题 ICMJE | Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps | ||
| 简要概况 | This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
46 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2022 | ||
| 预计主要完成日期 | March 2022 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Age> 18 years - Performance Status 0 or 1 - Patient with less than 4 brain metastases [of a solid tumor with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible. - Brain injury (s) measuring between 5 and 30 mm in diameter - Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee - Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by : - hyperdense lesion on the non-injected CT (treatment scanner) and / or, - spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and / or, - lesion with hypo signal on T2 sequences * - Patient with controlled extra-cranial disease under systemic treatment (chemotherapy or targeted therapy): - illness in complete response - partial response or stable illness for more than 3 months - Absence of meningeal tumor invasion - Absence of brainstem metastasis - DS-GPA of 3 or more - Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, anti-angiogenic or other anti-cancer treatments). Treatments should be suspended for at least 7 days before the start of FSRT radiotherapy. The treatment can be resumed 7 days after the end of radiotherapy - Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask - Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol - Patient affiliated to a social security scheme - Patient giving written consent Exclusion Criteria: - Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma - Patient with a concomitant neurodegenerative disease - Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose) - Contraindication to brain MRI or gadolinium injection - Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s) - Radiosensitizing systemic disease (Neurofibromatosis ...) - Thrombocytopenia less than 100,000 cells / mm3 - Anticoagulant treatment with curative dose, and / or anti-platelet aggregation during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 months after completion of FSRT, the patient is eligible. - Hemorrhagic metastasis (s) of the brainstem - Planning of the treatment on the target metastasis delivering a dose> 5 Gy on other metastases concomitant - Patient with prior cerebral stereotactic irradiation - History of total brain irradiation - Evolutionary extra-cranial disease - Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study - Participation in a therapeutic trial within 30 days - Patient deprived of liberty or under guardianship | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | France | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Centre Francois Baclesse | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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