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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01587976
Acronym
HQOL
Enrollment
100
Registered
2012-04-30
Start date
2011-06-30
Completion date
2015-12-31
Last updated
2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis, Quality of Life

Keywords

Health related quality of life, Colorectal liver metastasis, surveillance

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.

Interventions

None listed

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Health related quality of life after liver resection in combination with chemotherapy12 months after surgeryThe 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

MeasureTime frameDescription
Identifying possible clinical parameters influencing the HQoL after liver resection.Up to one year after surgery, maybe longerExamples of parameters: complications, extent of surgery, chemotherapy.

Countries

Norway

Contacts

Primary ContactJon-Helge Angelsen, MD
jhangelsen@gmail.com+4797520572
Backup ContactAsgaut Viste, Professor
asgaut.viste@helse-bergen.no+5755972760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026