A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.
详细描述
Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.
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
- •4 or less distinct sites of active disease. Locoregional disease counts as one site
- •All sites of disease can safely be encompassed by radiation fields to doses ≥ 45 Gy (biologic equivalent dose) and/or removed completely with surgery and/or completely ablated with other appropriate site-specific techniques.
- •sufficient blood cell counts and adequate liver function
排除标准
- •Hematologic malignancies
- •Distinct sites of disease > 4
- •Karnofsky Performance Status < 70
- •Unexplained weight loss > 10 %
- •HIV, chronic viral hepatitis, or any chronically active infection
- •Life expectancy < 6 months for any reason
研究组 & 干预措施
Definitive locoregional treatment
All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease.
干预措施: Complete Surgical Removal (Procedure)
Definitive locoregional treatment
All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease.
干预措施: Stereotactic Radiosurgery (Radiation)
Definitive locoregional treatment
All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease.
干预措施: Ablative external beam radiation dose (Radiation)
Definitive locoregional treatment
All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease.
干预措施: Subtotal surgical removal plus ablative radiation dose (Procedure)
Definitive locoregional treatment
All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease.
干预措施: Radioembolization (Radiation)
结局指标
主要结局
Survival
时间窗: 5 years
Overall and disease-specific survival, to be assessed at 1, 3, and 5 years.
次要结局
- Progression free survival (PFS)(5 years)
- Locoregional disease control(5 years)
- Toxicity(5 years)