PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of major wound complications
研究概览
简要总结
This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures.
Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.
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
- •Adult patients (≥18 years of age)
- •Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
- •WHO/ECOG status ≤2
排除标准
- •History of prior local radiation therapy
- •Inability to tolerate treatment position for duration of simulation or treatment
- •Tumor originating in retroperitoneal location
- •Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
- •Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
- •Confirmed pregnancy.
研究组 & 干预措施
Pre-operative hypofractionated proton therapy
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
干预措施: hypofractionation (Radiation)
结局指标
主要结局
Rate of major wound complications
时间窗: 90 days after surgery
Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…\[including\] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.")
次要结局
- Incidence of acute grade ≥3 adverse events(2 years after treatment)
- Rate of metastasis free survival(1 and 2 years after enrollment)
- Rate of pathologic complete response(through study conclusion (estimated 5 years from opening))
- Rate of local recurrence free survival(1 and 2 years after enrollment)
- Rate of late grade ≥2 radiation toxicity(median two year follow up)
- Musculoskeletal Tumor Rating Scale scores(baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years)
- Toronto Extremity Salvage Score (TESS) scores(baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years)
- Functional Assessment of Cancer Therapy-General (FACT-G) scores(baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years)