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

NCT ID: NCT01587976

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Metastasis; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

August Bakke, Professor

Role: STUDY_DIRECTOR

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

Locations

Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital

Bergen, Bergen, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jon-Helge Angelsen, MD

Role: CONTACT

jhangelsen@gmail.com

+4797520572

Asgaut Viste, Professor

Role: CONTACT

asgaut.viste@helse-bergen.no

+5755972760

Facility Contacts

Arild Horn, MD, PhD

Role: primary

arild.horn@helse-bergen.no

+4755972797

Other Identifiers

2011/570

Identifier Type: -

Identifier Source: org_study_id