NCT02747303招募中2 期
The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
研究概览
简要总结
This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.
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
- 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
- •Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
- •Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
- •Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
- •Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
- •Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
- •Diagnosis of leptomeningeal disease.
- •Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
- •Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
- •Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR<30, gadolinium allergy).
研究组 & 干预措施
Stereotactic Radiosurgery to 0 mm GTV to PTV margins
Experimental
干预措施: Stereotactic Radiosurgery (Procedure)
Stereotactic Radiosurgery to 2 mm GTV to PTV margins
Active Comparator
干预措施: Stereotactic Radiosurgery (Procedure)
结局指标
主要结局
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
时间窗: 6 months
Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.
次要结局
- Progression free survival (PFS) rates estimated by the Kaplan-Meier method(2 years)
- Overall survival rates(2 years)
- Rates of radiation necrosis(2 years)
- Rates of pseudoprogression(2 years)
- Local failure rates(2 years)
- Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities(90 days)
- Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities(2 years)
- Rates of distant intracranial failure(2 years)
- Rates of salvage therapy(2 years)
- Association between dose and risk of radionecrosis or pseudoprogression(2 years)
研究者
研究点 (2)
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