NCT03175146Unknown不适用
Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Response rate within the treated liver lesion
研究概览
简要总结
The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy
详细描述
SBRT for Oligo-metastatic Colorectal cancer
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Colo-rectal Cancer
- •1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- •Surgically resected primary disease
- •Technically/medically inoperable or patient declined surgery
- •Progression or Stability after at least 1 Line of chemotherapy
- •Adequate marrow function: Hb > 80g/L, Platelets > 100 x 109/L, White blood cell > 2 x 109/L
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Age > 18 years
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •Prior liver radiation, or radiation in close proximity to planned treatment sites
- •Prior invasive malignancy
- •Severe, active co-morbidity
- •Active hepatitis or Child Pugh Score B (9) or worse
- •Pregnant or nursing women
- •Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis
- •Life expectancy < 6 mo from any cause
- •Concurrent chemotherapy
- •Response to prior chemotherapy with minimal measurable disease in liver
研究组 & 干预措施
Experimental
Experimental
Stereotactic Body Radiation Therapy
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Response rate within the treated liver lesion
时间窗: 6 months
RECIST Response
次要结局
- Progression-free survival(Up to 5 years)
- Toxicity(From date of randomization up to 5 years)
- Quality of Life(From date of Randomization to Death or Progression or 5 years whichever comes first.)
- Median survival(From date of randomization upto 5 years)
- Overall survival(From date of randomization upto 5 years)
研究者
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