Short Course Pre-operative RadiothErapy for Soft Tissue SarcOmas - a Phase I/II Trial (PRESTO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5
研究概览
简要总结
Soft tissue sarcomas (STSs) are malignant tumours that arise in any of the mesodermal tissues in the body including muscles, fibrous tissues, bone and cartilage, adipose tissue, and blood vessels, most frequently in the extremities (40%), trunk and retroperitoneum (40%).
Traditionally, the prescription schedule for conventional preoperative RT is a regimen of 50 Gy in fractions of 1.8-2 Gy per day. Concerns regarding this regimen include the delay to definitive surgery and the higher rate of wound complications compared to post-operative radiotherapy. Hypofractionated RT is a prescription schedule in which the total dose of radiation is delivered in larger doses per fraction in fewer fractions allowing the delivery of a higher biologically effective dose (BED) to the tumour than with conventional RT [7] during a shorter period of time.
详细描述
This will be a phase I/II study of hypofractionation delivering five fractions (one fraction delivered every 2nd day) of 7 Gy of external beam radiotherapy over 5 fractions (one and half week period) in patients with localized STSs who are planned to receive pre-operative radiotherapy. Patients will undergo surgery 4-6 weeks after completion of RT.
Pre-treatment evaluation will be according to standard practice:
History and Physical Exam
- height,
- weight
- history (diabetes, vascular disease)
Radiology
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
- •Histologically proven STS of the extremities, above the knee, or trunk following review by our pathologist
- •Lesions smaller than 15cm in largest dimension
- •Deemed appropriate for preoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist
- •Lesion is primary or locally recurrent. Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital are NOT eligible
- •No previous radiation therapy
- •ECOG 0-2 (or Karnofsky Performance Status ≥ 70) within 60 days prior to registration
- •Resectable primary lesion with or without distant metastasis
- •Patient must be able to provide study-specific informed consent prior to study entry
- •Patient is available for treatment and follow-up
排除标准
- •Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital
- •Lesions below the knee
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy, unless continually disease free for a minimum of 5 years
- •Regional lymph node involvement
- •Previous irradiation to the area to be treated
- •Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up
结局指标
主要结局
Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5
时间窗: 1 month
To assess, skin reactions and wound healing
次要结局
- Physicians Muscle Tumor Rating Scale(1 year)
研究者
Fabio Cury
Principal Investigator/Radiation Oncologist
McGill University Health Centre/Research Institute of the McGill University Health Centre