Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.
详细描述
Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.
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
- •age between 18 - 75 years old
- •colorectal adenocarcinoma pathologically
- •without any chemotherapy or radiotherapy
- •unresectable liver metastasis and without other metastasis
- •resectable colorectal cancer
- •suitable for chemotherapy
- •agreed by patients
排除标准
- •age below 18 years old or greater than 75 years old
- •haven't pathological diagnosis of colorectal adenocarcinoma
- •with any chemotherapy or radiotherapy
- •resectable liver metastasis or without other metastasis
- •unresectable colorectal cancer
- •unsuitable for chemotherapy
- •not agreed by patients
研究组 & 干预措施
arm A
Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
干预措施: chemotherapy ± targeted therapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 3 years
Time from randomization to the date of disease progression or to death of any cause
次要结局
- Tumor response(Up to 6 months)
- Surgical complications(30 days after surgery)
- Overall survival(Up to 3 years)
- Secondary resection rate Second radical resectability(Up to 6 months)
- Toxicity of chemotherapy(Up to 6 months)
