A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway

February 10, 2022 updated by: Norwegian University of Science and Technology
The main objective is to provide original research results that may change clinical practice related to metastatic colorectal cancer. The study will evaluate treatment and patient care at different stages of the disease trajectory and the use of health care for this large group of patients. It will be possible to compare the effectiveness of chemotherapy, radiotherapy and symptomatic treatment given to "real life" patients with the efficacy reported in randomised clinical trials. By using longitudinal information on imaging, biomarkers, clinical staging and place of care it will be possible to improve patient classification at various stages of the disease. Based on this, a more appropriate, individualized treatment for colorectal cancer may be recommended during the phases of the disease trajectory. Participation in this project will not influence the treatment for colorectal cancer. All patients will be treated and followed-up according to current regional and national guidelines.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The available evidence-based knowledge of patient management is translated into regularly updated clinical guidelines for diagnosis, staging and treatment. The guidelines represent the basis for oncology care in Norway, and health care providers are expected to follow these guidelines. Current guidelines are derived from studies where patients are highly selected and not representative for the whole cohort of patients with metastatic disease. One can speculate if the results of trials conducted in regional centers can be generalized to whole populations in a region. In this respect it will be valuable to study advanced colorectal cancer in the whole population of Middle-Norway, with both one regional center and all other hospitals in the area. More knowledge is needed for the optimal selection of treatment for individual patients. In relation to symptom relief, physical and psychological functioning and overall quality of life, there is clearly a lack of high quality research.

A longitudinal follow-up of a large number of metastatic colorectal cancer patients with regular assessments has not been previously launched. The existing infrastructure in Norway makes the study feasible and will provide high internal and external validity related to clinical outcomes. The study will constitute a unique platform for comprehensive research aimed at this patient group. It also provides a concept that can be transferred to other major diseases, and it can be extended to other health regions of Norway.

Study Type

Observational

Enrollment (Actual)

354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansund, Norway
        • Kristiansund Hospital
      • Levanger, Norway
        • Levanger Hospital
      • Molde, Norway
        • Molde Hospital
      • Namsos, Norway
        • Namsos Hospital
      • Trondheim, Norway
        • St Olavs Hospital
      • Volda, Norway, N-6100
        • Volda Hospital HF
      • Ålesund, Norway
        • Alesund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosis of metastatic colorectal cancer treated with a curative or non-curative intention, or local disease not treated with a curative intention.

Description

Inclusion Criteria:

  • Colon or rectal cancer with synchronous metastases.
  • Colon or rectal cancer with metastatic relapse after curative primary treatment (for localized disease or maximum one operation for distant metastases)
  • Localized colon or rectal cancer that due to tumor or patient related factors are not treated with a curative intent
  • Written informed consent. In patients not able to consent due to cognitive impairment consent can be by proxy

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 3 years or until death
Cancer-specific and overall survival according to treatment, age, sex, biological markers
3 years or until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 3 years or until death
reported on PG-SGA, patient version
3 years or until death
Patient expectations
Time Frame: 3 years or until death
patient expectations about effects of chemotherapy and satisfaction with treatment
3 years or until death
WHO performance status
Time Frame: 3 years or until death
3 years or until death
Toxicity of therapy
Time Frame: 3 years or until death
Number of dose reductions and treatment delays
3 years or until death
Toxicity of therapy
Time Frame: 3 years or until death
Common Terminology Criteria for Adverse Events (CTCAE) v4.0; grade 3-4 for the following items: Hematology, infectious, gastrointestinal, neurological and thromboembolism
3 years or until death
Health related quality of life
Time Frame: 3 years or until death
reported on EORTC QLQ-C30
3 years or until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Midt-Norge

Investigators

  • Study Director: Stein Kaasa, MD PhD, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Anticipated)

January 15, 2023

Study Completion (Anticipated)

January 15, 2023

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 23, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1361

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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