NCT02149784Unknown3 期
Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old
- •both genders
- •ECOG:0-2 score
- •Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge
- •CT,MRI,or PET-CT confirmed metastasis
- •MDT confirmed unresectable metastasis lesion
- •No evidence of obstruction, bleeding, perforation
- •WBC≥4.0×109/L，Neu ≥2.0×109/L，PLT≥100×109/L
- •No contraindication for chemotherapy
- •No evidence of other malignant tumor
- •Expected survival time > 6 months
排除标准
- •mCRC patients who did not respond to first line chemotherapy
- •Require surgical intervention during the primary tumor-related symptoms
- •Obvious coagulopathy
- •Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia
- •Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
- •Pregnant or lactating women or women of childbearing age who refuse to accept contraception.
- •Nearly three months participated in clinical trials of other persons.
- •Mental abnormalities
研究组 & 干预措施
Surgical treatment group
Experimental
Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.
干预措施: Surgical resection of primary tumor (Procedure)
Chemotherapy group
No Intervention
Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Number of Participants with Adverse Events both in surgery group and chemotherapy group(2 years)
研究者
Gong Chen
Sun Yat-Sen University Cancer Center
Sun Yat-sen University
研究点 (1)
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