Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases

• Conditions: Metastasis; Quality of Life

• Registration Number: NCT01587976
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Status Verified: 2013-09
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• Drop out of questionnaire after surgery
• Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health related quality of life after liver resection in combination with chemotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Identifying possible clinical parameters influencing the HQoL after liver resection.	Up to one year after surgery, maybe longer	Examples of parameters: complications, extent of surgery, chemotherapy.

Trial Locations

Locations (1)

Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital; 🇳🇴 Bergen, Norway