Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Resectable outcome
研究概览
简要总结
This single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.
详细描述
Patients with liver-only metastases colorectal cancer could potentially be cured following surgical resection of metastases. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI has been associated with higher R0 resection.
Eighty-nine eligible patients will be recruited at Cho Ray hospital in Vietnam. Patients will receive neoadjuvant FOLFOXIRI regimen every two weeks for up to 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of digestive surgeons, hepato-biliary surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-limited metastatic colorectal cancer. Moreover, this study will assess the surgical outcome, the response rate, the survival rate, the safety of triple drug chemotherapy and the association between conversion operable disease and various survival rate and patient's characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients from 18 to 75 years
- •Able to give informed consent
- •Have a histological adenocarcinoma diagnosis of colorectal cancer
- •Resected or operable colorectal primary tumor
- •Initially unresectable liver lesion considered by multidisciplinary team (MDT)
- •World Health Organisation performance status (ECOG PS) 0, 1
- •Adequate complete blood count, liver and renal function
排除标准
- •Prior history of other active malignancies
- •Unmeasurable lesion according to RECIST criteria v.1.1
- •Recurrence of colorectal cancer
- •Resection or ablation of liver lesion
- •Distant metastases outside the liver
- •Patients who have received prior chemotherapy with Oxaliplatin, Irinotecan, Capecitabine, 5-Fluoro-uracil.
- •Concomitant uncontrollable medical status ie. symptomatic cardiac disease, infarction within 24 months, uncontrollable cardiac dysrhythmia, active infectious disease
- •Pathology of the liver lesion except adenocarcinoma metastasis from colorectal cancer.
研究组 & 干预措施
Un-resectable synchronous liver limited metastasis colorectal cancer
Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles.
干预措施: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen (Drug)
Un-resectable synchronous liver limited metastasis colorectal cancer
Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles.
干预措施: synchronous resection surgery (Procedure)
结局指标
主要结局
Resectable outcome
时间窗: 8 weeks
R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
次要结局
- The incidence of chemotherapy related adverse events(2 weeks)
- Progression free survival(5 years)
- Overall survival(5 years)
研究者
Vuong Dinh Thy Hao
Doctor, Medical Oncologist, Cho Ray Hospital at Ho Chi Minh City
Cho Ray Hospital