Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI Regimen (Folinic Acid, 5-fluorouracil, Oxaliplatin and Irinotecan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Patients' characteristic
研究概览
简要总结
Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.
The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients
详细描述
In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.
According to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.
In VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017
排除标准
- 未提供
研究组 & 干预措施
Metastatic colon cancer patients
Colon cancer patients with metastase at the diagnostic time, impossibility of radical resection, adenocarcinoma, treated by at least 3 cycles of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
Patients' characteristic
时间窗: 4 years
Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable
Response rate after 3 cycles
时间窗: At the end of Cycle 3 (each cycle is 4 weeks)
Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Response rate after 6 cycles
时间窗: At the end of Cycle 6 (each cycle is 4 weeks)
Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Mean of the progression free survival
时间窗: 4 years
The median progression free survival of the study population
Correlation between response rate and percentage of chemotherapy dosage
时间窗: 4 years
Prognostic factor of response rate
Correlation between response rate and metastatic site
时间窗: 4 years
The average size of the hepatic metastatic lesion in the study
Prognostic factor for response rate after 3 cycles
时间窗: At the end of cycle 3 (each cycle is 4 weeks)
Evaluation of predictor of response rate
Correlation between response rate and histopathology
时间窗: 4 year
Prognostic factor of response rate
Prognostic factor for response rate after 6 cycles
时间窗: At the end of cycle 6 (each cycle is 4 weeks)
Evaluation of predictor of response rate
Prognostic factor of progression free survival
时间窗: 4 years
Evaluation of predictor of progression free survival
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(4 years)
- Overall survival after 12 months(12 months after the last patient finish chemotherapy)
- Overall survival after 24 months(24 months after the last patient finish chemotherapy)
研究者
Bui My Hanh
Director, Science Research and International Cooperation Unit
Hanoi Medical University