NCT01978249终止不适用
A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
研究概览
简要总结
Short description for lay public, include brief statement of the study hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : between 20 and 90 years old
- •Histologically confirmed adenocarcinoma of the colon or the upper rectum
- •Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions.
- •Patients with no primary cancer related symptoms.
- •ECOG performance status of 0 - 2
- •Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
- •ASA score of < 3
- •An informed consent form has been signed by the patient.
排除标准
- •The patient received adjuvant chemotherapy within the past 6 months.
- •The patient received chemotherapy for metastatic colon cancer.
- •The patient was planning to have curative surgery for the metastatic lesions.
- •The primary cancer is unresectable.
- •Patients with peritoneal carcinomatosis.
- •Patients with mid and low rectal cancer (< 10cm)
- •Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
- •ASA score of > 4
- •The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
- •Patients with an active infection, which need antibiotic therapy, during the randomization period.
- •Pregnant or breastfeeding women
- •Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period).
- •Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
研究组 & 干预措施
Chemotherapy first without primary tumor resection
Experimental
Patients will receive chemotherapy first without primary tumor resection.
干预措施: Systemic chemotherapy (Procedure)
Primary tumor resection followed by chemotherapy
Active Comparator
Patients will receive primary tumor resection followed by chemotherapy.
干预措施: primary tumor resection (PTR) (Procedure)
结局指标
主要结局
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
时间窗: 2 years after allocation
Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis.
次要结局
- Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.(2 years after allocation)
研究者
研究点 (13)
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