Prospective Observational Study Studying the Influence of the Presence of Liver Cirrhosis During Chemotherapy for ENT Cancer, Upper Digestive Tract Cancer or Colorectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis
研究概览
简要总结
Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs.
Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies.
The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy.
The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer.
Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients' outcomes with a control group of matched non-cirrhotic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Follow-up for the following cancers: upper digestive sphere (stomach, esophagus, pancreas, bile ducts), colorectal, ENT
- •Theoretical indication of conventional chemotherapy based on 5FU, anthracyclins, platinum salts, gemcitabin, taxans, irinotecan or antiangiogenic drugs, anti-EGFR or anti-HER 2 therapies, according to management guidelines
- •Beneficiary of a social security system
- •Dated and signed non-opposition consent
排除标准
- •Other concomitant primary cancer
- •Pregnant women
- •Patients under guardianship, curatorship or justice protection
结局指标
主要结局
Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis
时间窗: before the chemotherapy initiation, within 45 days of multidisciplinary board
次要结局
- Survival time(the date of death, the date of last news or the point date (12 months).)
- Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy(within 45 days of multidisciplinary board.)
- Frequency of chemotherapy side effects according to CTCAE version 5.0 classification in cirrhotic patients who have received chemotherapy(Up to 5 years after chemotherapy)
- Progression-free survival time(the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months).)