SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
试验速览
- 阶段
- 不适用
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
研究概览
简要总结
The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.
详细描述
The investigators wish to evaluate the safety and feasibility of MR-guided stereotactic radiation to patients with infra-diaphragmatic oligometastatic disease including quality of life assessments and patient-reported outcome measures. Further, the investigators assess clinical response among patients with oligometastatic disease (OMD), defined as up to five metastases in up to three different organs.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology or cytology proven non-haematological cancer.
- •At least one metastasis should be localized in the infra-diaphragmatic soft tissue.
- •Eastern Cooperative Oncology Group (ECOG) scale of performance status ≤
- •≥ 18 years old.
- •Life expectancy > 6 months.
- •Target diameter (GTV) ≤ 5 cm.
- •Metastatic lesions must be visible, imaging defined targets and suitable for treatment with SABR.
- •In case of de novo OMD and oligometastatic recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
- •In case of oligoprogressive disease (OPD) * and induced OMD ** only 3 metastases (including the primary tumour) are allowed.
- •All metastatic sites are treated or planned for ablative therapy (including surgery). For OPD, only the sites in progression is required to fulfil this criterion.
- •A baseline scan within 28 days of inclusion (PET-CT or CT and MR scanning).
- •No curative intended treatment option available.
- •An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide.
- •Ability to understand and the willingness to sign a written informed consent document.
- •If the target is in the liver, a Child-Pugh Score A is required.
排除标准
- •Patient cannot tolerate physical set up required for SABR.
- •Active bowel obstruction.
- •Uncontrolled intercurrent illness.
- •Medical contraindication to undergoing MR-imaging.
- •Pregnancy.
- •Patients with uncontrolled brain metastases.
- •Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
- •If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints.
结局指标
主要结局
Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
时间窗: Assessed at 1 year.
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
次要结局
- Freedom from local progression.(Assessed at week 6, 12, 24, 36, and 52.)
- Progression free survival.(Assessed at week 6, 12, 24, 36, and 52.)
- Time to progression (TTP) outside the radiation field.(Assessed at week 6, 12, 24, 36, and 52.)
研究者
Mette Felter
Principal Investigator, MD, Mette Felter
Herlev Hospital