NCT03696680招募中2 期
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Centre Francois Baclesse4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
研究概览
简要总结
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age> 18 years
- •Performance Status 0 or 1
- •Patient with less than 4 brain metastases [of a solid tumor, including melanoma, 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 *
- •Absence of meningeal tumor invasion
- •Absence of brainstem metastasis
- •DS-GPA depending on the histological type (https://brainmetgpa.com/#start):
- •Lung Adecarcinoma: DS-GPA 2 or +
- •Non-adenocarcinoma lung: DS-GPA 2.5 or +
- •Kidney: DS-GPA 2.5 or +
- •Breast: DS-GPA 2.5 or +
- •Digestive cancer: DS-GPA 3 or +
- •Melanoma: DS-GPA 1.5 or +
- •Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, 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. It's not mandatory to suspend immunotherapy
- •Life expectancy estimated at over 6 months
- •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
排除标准
- •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, and / or anti-platelet aggregation with curative et prophylaxic dose during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 weeks 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
- •Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
- •Participation in a therapeutic trial that could compromise the conduct of study
- •Patient deprived of liberty or under guardianship
结局指标
主要结局
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
时间窗: 6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria
时间窗: 6 months after end of Stereotactic radiation therapy
次要结局
未报告次要终点
研究者
研究点 (4)
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