NCT05301283招募中2 期
Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Rate of Favorable Pathologic Response (FPR)
研究概览
简要总结
The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
- •Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
- •Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
- •Primary site deemed resectable prior to the start of trial
- •American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
- •Patients must have clinically or radiographically evident measurable disease at the primary site.
- •Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to
- •Deemed a surgical candidate
- •Participant agrees to blood and plasma preservation for future analysis.
排除标准
- •Contraindications to an MRI
- •Positive urine pregnancy test
- •Gross total excision of primary STS, including an unplanned excision
- •Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
- •Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
- •Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
结局指标
主要结局
Rate of Favorable Pathologic Response (FPR)
时间窗: Week 10
Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis \>/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.
次要结局
- Percentage of tumor with clear margin and positive margin(Weeks 10-13)
研究者
研究点 (2)
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