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Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study

Open (Enrolling)
Metastasis, Quality of Life

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Trial Information

Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Health related quality of life after liver resection in combination with chemotherapy

Outcome Description:

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.

Outcome Time Frame:

12 months after surgery

Safety Issue:


Principal Investigator

August Bakke, Professor

Investigator Role:

Study Director

Investigator Affiliation:

Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway


Norway:National Committee for Medical and Health Research Ethics

Study ID:




Start Date:

June 2011

Completion Date:

December 2013

Related Keywords:

  • Metastasis
  • Quality of Life
  • Health related quality of life
  • Colorectal liver metastasis
  • surveillance
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms