NCT04503772已完成2 期
Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
Centre Jean Perrin16 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Evaluation of 6-months local control rate after preoperative SRS
研究概览
简要总结
STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with 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
- •≤ 4 distinct brain metastases, one with surgical indication
- •Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
- •≤ 5 cm larger diameter
- •Karnofsky performance status ≥ 70
- •No contraindication for MRI
- •Possibility for the patient to be treat with both surgery and stereotactic radiotherapy
- •≥ 18 years old
- •Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA)
- •Written inform consent signed
- •Affiliation to the French social security system
- •For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS).
排除标准
- •Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer
- •Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma
- •Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery
- •> 4 brain metastases
- •Contraindication to anaesthesia, MRI or gadolinium injection
- •Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope
- •Pregnant or breastfeeding woman
- •Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment
- •Documented leptomeningeal injury
- •History of irradiation of the encephalon in toto
- •History of stereotactic radiotherapy on metastasis to be operated on
- •Non-candidate patient for surgery
- •Surgical delay > 3 days compared to stereotactic radiotherapy
- •Estimated survival < 6 months by DS GPA
- •Patient under guardianship or curators
- •Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment
- •Woman of childbearing age without effective contraception
- •Patient participating in another intervention study within 4 weeks prior to inclusion
结局指标
主要结局
Evaluation of 6-months local control rate after preoperative SRS
时间窗: 6 months after preoperative SRS (M6)
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
次要结局
- Evaluation of cerebral distant control(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Determination of predictive factors for local brain control, complication and prognosis factors for survival(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Evaluation of 1-year radionecrosis rate after preoperative SRS(12 months after preoperative SRS (M12))
- Evaluation of quality of life(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Evaluation of overall survival(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Evaluation of 1-year local control rate after preoperative SRS(12 months after preoperative SRS (M12))
- Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Rate of leptomeningeal relapses(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
- Evaluation of cognitive function(At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12))
研究者
研究点 (16)
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