Clinical trial NCT01587976: Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases
Official title: Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastasis
Quality of Life
Keywords: Health related quality of life
Colorectal liver metastasis
surveillance
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
First posted: 2012-04-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resectable colorectal liver metastases treated at Haukeland and Stavanger University hospital, Norway.

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.

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.

Primary outcomes:
measure: Health related quality of life after liver resection in combination with chemotherapy
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Identifying possible clinical parameters influencing the HQoL after liver resection.
timeFrame: Up to one year after surgery, maybe longer
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital
Study officials:
affiliation: Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway
name: August Bakke, Professor
role: STUDY_DIRECTOR
References: