Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Health related quality of life after liver resection in combination with chemotherapy
研究概览
简要总结
The purpose of this trial is to study health related quality of life (HQoL)after resection of colorectal liver metastases combined with perioperative chemotherapy. The investigators want to study if an aggressive, life prolonging and multimodal treatment can be defended from a quality of life perspective.
详细描述
Background: Hepatic resection is the only treatment with potential curative intent for patients having colorectal liver metastases. Combined with chemotherapy, the overall 5-year survival is 40-50%. The disease free 5-year survival is about 20%, and about 70% of resected patients experience recurrence from their disease. Even if surgery is superior all other treatments, most patients will finally die from their cancer. However; surgery contributes by adding years of life, and for a minority, a disease free life. There has been much effort to study predictors for outcome after surgery, but little has been focused on quality of life following this treatment.
Method: EORTC Validated questionnaire (European Organisation Research of Treatment of Cancer) version QLQ-C30 (3.0) and QLQ LMC21. The patients fill out the questionnaire before surgery as a baseline, and then after 3,6 and 12 months after surgery. The investigators also register important clinicopathological data about each patient prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver metastasis from colorectal cancer
- •Resectability, with intension of R0 resection
- •No macroscopic tumor left after surgery
- •Patients with combined resectable extrahepatic tumors are also included.
- •Patients must complete the questionnaire before the operation.
排除标准
- •Drop out of questionnaire after surgery
- •Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.
结局指标
主要结局
Health related quality of life after liver resection in combination with chemotherapy
时间窗: 12 months after surgery
The EORTC board has made validated questionaries with manuals for measuring quality of life. The important focus is to see if and when patients gain their HQoL as they did have before surgery.
次要结局
- Identifying possible clinical parameters influencing the HQoL after liver resection.(Up to one year after surgery, maybe longer)