A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Proportion of patients with lack of progressive disease for the index site at 1 year
研究概览
简要总结
This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.
The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
详细描述
Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.
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
- •Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
- •Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
- •Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
- •Oligometastatic disease, maximum of 5 lesions.
- •At least one lesion is suitable for stereotactic body radiotherapy
- •All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
- •At least 18 yrs old
排除标准
- •Previous radiotherapy to the intended treatment site
- •Patient cannot tolerate physical set up required for SBRT
- •Active bowel obstruction, if treating abdominal/pelvic site
- •Chemotherapy within 2 weeks of intended radiation therapy
- •Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
- •Pregnancy
研究组 & 干预措施
Stereotactic Body Radiation Therapy
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
干预措施: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance (Radiation)
结局指标
主要结局
Proportion of patients with lack of progressive disease for the index site at 1 year
时间窗: 10 years
CT will be used for evaluation of the status of the local disease at the index site.
次要结局
- Time to local progression for the index site(s)(10 years)
- Acute toxicity within 90 days of first fraction of radiotherapy(10 years)
- Time to distant disease progression (beyond known sites of oligometastases at time of study entry)(10 years)
- Describe symptom profile(10 Years)
- Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities(10 years)
- Number of index lesion(s) with lack of progressive disease at 1 year.(10 years)
- Late toxicity occuring beyond 90 days related to SBRT.(10 year)