A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 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. The subject should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
This trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject whom should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
- •Over 18 years
- •Proper organ function (hepatic transaminases : < ULN ⅹ5, Bilirubin: < ULNⅹ2, creatinine (serum): < ULNⅹ 1.5, PLT > 100,000Ul, ANC > 1,500/Ul
- •more than one target lesion (standard by RECIST 1.0)
- •Who should sign on the Informed consent form before participate the trial.
排除标准
- •Metastasis in other organ except liver (No matter whether have resection or not)
- •Chronic active hepatitis or cirrhosis
- •History of treatment for colorectal cancer
- •Subject pregnant or breast feeding
- •Uncontrolled disease (eg. infection, hypertension, heart failure, Myocardial Infarction within 6months)
- •Have been used FOLFOX as an adjuvant therapy
- •Have had adjuvant therapy within 6months
- •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.
结局指标
主要结局
complete resection (R0) rate for rectal and liver lesions.
时间窗: after surgical resection
Complete resection (R0 resection) is defined as no residual cancer cells in the resection margn both primary recal mass and liver metastases after simultaneous surgical resection.
次要结局
- Overall survival rate(participants will be followed until death)
- Response rate (RECIST V1.0)(every 4 cycles)
- Toxicity profile(participants will be followed until disease progression or death)
- Progression free survival time(participants will be followed until disease progression or death)