Reduction of Dose and Volume in Postoperative Radiation for Extremity Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 7
- 主要终点
- Assessment of local control at 2 years.
研究概览
简要总结
The investigators are doing this study to find out whether lowering the dose of postoperative radiation therapy and targeting a smaller area of tissue for treatment is as effective as the standard dose and volume of radiation therapy to control soft tissue sarcoma after surgery. They also want to find out whether the study approach causes fewer and less severe long-term side effects than the standard approach.
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
- •Patients must be diagnosed with a primary soft tissue sarcoma of the extremity, confirmed by MSKCC pathologic review
- •Age at the time of enrollment of ≥18 years
- •Patients must have undergone margin-negative oncologic resection of their primary tumor, as confirmed by MSKCC pathologic review
- •Patients must be able to start radiation within 3 months from time of surgery
- •°If patient is receiving adjuvant chemotherapy, patient must start RT no longer than 3 months past their chemo treatment.
- •Female patients of childbearing potential must have a negative serum pregnancy test within 14 days of radiation start (or if urine test, within 24 hours of radiation start)
- •Sexually active patients of childbearing potential must agree to use effective contraception.
- •The use of chemotherapy will not be dictated by this trial. Patients are allowed to receive chemotherapy at the discretion of the disease management team (as is standard practice to make individualized decisions for each patient regarding the use of chemotherapy).
排除标准
- •Patients with positive margins after surgical resection as indicated by MSKCC pathologic review
- •Patients with diagnosis of superficial myxofibrosarcoma with indistinct/infiltrative borders on preoperative MRI16 (see Appendix Figure 1 for reference figure)
- •Patients with multifocal disease in the extremity
- •Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
- •Patients with a differentinvasive cancer requiring active treatment at the time of enrollment.
- •Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study
研究组 & 干预措施
extremity soft tissue sarcoma (STS)
Postoperative radiation therapy to the primary site with a reduction in radiation dose and volume. Specifically, the tumor bed plus a margin of 2cm craniocaudally and 1.5cm radially will be utilized to create the clinical target volume. The total dose will consist of 50 Gy in 25 fractions.
干预措施: Intensity-modulated radiation therapy (IMRT) (Radiation)
结局指标
主要结局
Assessment of local control at 2 years.
时间窗: 2 years
will be assessed via imaging of the primary tumor site (MRI preferred, CT for patients who cannot get or tolerate an MRI). Imaging must take place at least annually for the first two years post-radiation. Local failure is defined as a relapse in the primary tumor bed.
次要结局
- overall survival(2 years)