OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Treatment safety
研究概览
简要总结
Currently, the standard of care for patients with diagnosed metastatic cancer is drug therapy (chemotherapy, targeted therapy, or immunotherapy). However, the approach to oligometastatic disease (1-5 metastases) is evolving. An increasing number of de novo, persistent, and progressive oligometastatic tumors are now being treated with curative intent, with radiation therapy among the most effective treatment options, applied to metastatic sites in ablative doses. Emerging results from the SABR-COMET 3 and 5 trials, which investigate stereotactic ablative radiotherapy for patients with 1-3 and 1-5 metastatic sites, demonstrate a clear improvement in overall survival. However, patients with more than five metastases remain in a gray area.
The aim of our study is to assess the safety and effectiveness of radiation treatment for patients with tumors of various localizations and 6 to 10 metastases in the bones and internal organs. Stereotactic radiation therapy will be applied to patients with persistent or progressive metastatic forms of tumors, without changing their ongoing drug therapy regimen.
详细描述
- A patient with a previously verified diagnosis of a malignant neoplasm of any localization (ICD 10-11 codes C) who meets the inclusion criteria, after approval by the tumor board for the study group, will undergo the following procedures:
Three-dimensional/four-dimensional computed tomography for simulation using specialized fixation devices (the choice of the CT method and fixation devices will depend on the location of the metastasis).
The resulting images will be added to the contouring program.
Delineation of targets and organs at risk will be performed.
Clinical volumes and error margins will be determined. 2. The total dose per target and dose limits for critical structures will be prescribed.
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
- •ECOG status 0-3
- •Persistent or progressive cancer disease with 6 to 10 metastases
- •≤ 5 metastases in one organ
- •Life expectancy > 6 months for intracranial lesions
- •Inability to surgically resect all metastatic lesions
- •Positive tumor board decision for trial inclusion
- •Signed informed consent
排除标准
- •ECOG status 4
- •De novo metastatic disease
- •Radiological complete response after drug therapy
- •Brain metastasis only
- •Brain metastasis > 3 cm, requiring neurosurgery
- •Size of any metastasis > 5 cm
- •Previous radiation therapy for any metastatic site
- •Leptomeningeal, pleural, or peritoneal carcinomatosis
- •Spinal cord compression, requiring neurosurgery
- •Invasion of great vessels, skin, or GI tract
- •Negative tumor board decision for trial inclusion
- •Unsigned informed consent
结局指标
主要结局
Treatment safety
时间窗: End of years 1, 2, 3, 4, 5 (study completion)
Radiation-induced toxicity (type and corresponding grade 1 to 5) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale.
次要结局
- Effectiveness (PFS)(From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.)
- Effectiveness (LC)(From the date of initiation until the date of documented radiological signs of metastasis relapse, assessed over a period of up to 60 months.)
- Effectiveness (OS)(From the date of initiation until the date of death from any cause, assessed over a period of up to 60 months.)
- Time-to-CTX-change(End of years 1, 2, 3, 4, 5 (study completion))
研究者
Konstantin Gordon
Principal Investigator
National Medical Research Radiological Centre of the Ministry of Health of Russia