Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Proportion of Participants with 2-year Local Control
研究概览
简要总结
One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.
Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.
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
- •Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
- •Participant refuses surgery or is aware that surgery is not recommended for them
- •Karnofsky performance status > 60
- •Able to understand and sign an informed consent form
排除标准
- •Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
- •Unable to undergo imaging or positioning necessary for radiotherapy planning
- •Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
研究组 & 干预措施
Hypofractionated Radiotherapy for Soft Tissue Sarcoma
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
干预措施: Hypofractionated Radiotherapy (Radiation)
结局指标
主要结局
Proportion of Participants with 2-year Local Control
时间窗: up to 2 years
The primary endpoint is 2-year local control, defined as the proportion of participants whose best response as determined per RECIST criteria using imaging is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of all participants who have received at least one fraction. Local control will be reported with an exact 95% confidence interval (CI).
Proportion of Participants With 2-year Local Control
时间窗: up to 2 years
The primary endpoint is 2-year local control, defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, Progressive Disease (PD), at least a 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient change for PR, PD, or CR.
次要结局
- Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site(up to 2 years)
- Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site(up to 5 years)
- Progression Free Survival(up to 5 years)
- Overall Survival(up to 5 years)
- Complete Response Rate(up to 5 years)
- Incidence of Acute Toxicity(up to 8 weeks)
- Incidence of Long Term Toxicity(up to 5 years)
- Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site(up to 5 years)
- Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade(up to 8 weeks)
- Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site(up to 2 years)