NCT03022734Unknown2 期
A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- complete resection (R0) rate for rectal and liver lesions
研究概览
简要总结
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
- •over 19 years
- •Eastern Cooperative Oncology Group 0-1
- •Proper organ function
- •more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
- •Who should sign on the Informed consent form before participate the trial.
排除标准
- •Metastasis in other organ except liver
- •Chronic active hepatitis or cirrhosis
- •History of treatment for metastatic colorectal cancer
- •Subject pregnant or breast feeding
- •Uncontrolled disease
- •Have had adjuvant therapy
- •Uncontrolled peripheral nerve infection
- •Alcoholic or drug addict
- •Subject currently is enrolled in or ≤30 days from ending other clinical trial.
- •History of other type of cancer except resolved from skin cancer and cervical cancer.
研究组 & 干预措施
chemotherapy with radiotherapy
Experimental
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
干预措施: chemotherapy (Drug)
chemotherapy with radiotherapy
Experimental
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
干预措施: radiotherapy (Radiation)
结局指标
主要结局
complete resection (R0) rate for rectal and liver lesions
时间窗: after surgical resection, an average of 24 weeks
次要结局
- Response rate (RECIST V1.1)(8 weeks)
研究者
Sang Joon Shin
Professor
Yonsei University
研究点 (1)
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