NCT04427228撤回2 期
MIGRAINE: Randomized trIal of Single Versus Multifraction Radiosurgery on Immunotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Multi-Fraction SRS superiority compared to single fraction SRS
研究概览
简要总结
This study is meant to compare different surgical approaches to brain cancer.
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 (Care Provider)
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
- •i. Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
- •ii. Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain metastases.
- •iii. Well-circumscribed, measureable intraparenchymal brain metastasis(s) with maximum tumor diameter ≤3.0 cm. If multiple metastases are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one metastasis must be ≥ 0.5 cm in maximum diameter to be considered measurable disease.
- •iv. Negative urine or serum pregnancy test done ≤ 21 days prior to CT simulation, for women of child bearing potential only.
- •v. Ability to understand and willingness to sign a written informed consent document.
- •vi. Must have received immunotherapy (PD-1/PD-L1 and/or CTLA-4 inhibitor(s)) within the past 6 months or plan on receiving immunotherapy within the next 1 month.
- •vii. Must have a Gustave Roussy Immune Score (GRIm-Score) of 0 or 1 (neutrophil-to-lymphocyte ratio > 6 = 1 point, LDH > Upper Limit of Normal = 1 point, and Albumin < 3.5 g/dL = 1 point).
排除标准
- •i. Diagnosis of germ cell tumor or hematologic malignancy. ii. Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
- •iii. Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately adjacent lesion(s) of interest or to the current lesion(s) of interest.
- •v. Prior history of pseudoprogression or radionecrosis from cranial radiotherapy.
- •vi. A neurosurgical resection cavity deemed too large by the radiation oncologist to be treated with a single fraction of stereotactic radiosurgery.
- •vii. Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR <30, gadolinium allergy).
- •viii. A Gustave Roussy Immune Score (GRIm-Score) > 1 (neutrophil-to-lymphocyte ratio > 6 = 1 point, LDH > Upper Limit of Normal = 1 point, and Albumin < 3.5 g/dL = 1 point).
结局指标
主要结局
Multi-Fraction SRS superiority compared to single fraction SRS
时间窗: 4 years
To determine if Multi-Fraction SRS will decrease the rate of radionecrosis when compared to single-fraction SRS for patients with small metastases and are on immunotherapy.
次要结局
- Overall Survival Rate(4 years)
- rate of individual metastases rates of edema(4 years)
- Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities(4 years)
- rate of individual metastases radionecrosis(4 years)
- Target metastasis progression(4 years)
- Time to any distant intracranial failure(4 years)
- Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities(4 years)
- Time to initiation of any combination(4 years)
- Rates of Symptomatic Edema(1 year)
研究者
研究点 (2)
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