NCT02395224

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

8.4 years

First QC Date

March 17, 2015

Last Update Submit

February 10, 2022

Conditions

Neoplasms, ColorectalNeoplasm Metastasis

Keywords

Follow-up studiesPrognosisPalliative careChemotherapy, adjuvantCost-benefit analysisPopulationAntineoplastic agents/Adverse effectsTerminal careMedical futilitySurvival rateNorway

Outcome Measures

Primary Outcomes (1)

  • survival

    Cancer-specific and overall survival according to treatment, age, sex, biological markers

    3 years or until death

Secondary Outcomes (6)

  • Nutritional status

    3 years or until death

  • Patient expectations

    3 years or until death

  • WHO performance status

    3 years or until death

  • Toxicity of therapy

    3 years or until death

  • Toxicity of therapy

    3 years or until death

  • +1 more secondary outcomes

Interventions

cancer treatment and follow-up according to current regional and national guidelinesOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ålesund Hospital

Ålesund, Norway

Location

Kristiansund Hospital

Kristiansund, Norway

Location

Levanger Hospital

Levanger, Norway

Location

Molde hospital

Molde, Norway

Location

Namsos Hospital

Namsos, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Volda Hospital HF

Volda, N-6100, Norway

Location

Related Publications (1)

  • Hatlevoll I, Kristensen AK, Solheim TS, Elvebakken H, Salvesen O, Oldervoll LM, Wibe A, Hofsli E. Do older patients with colorectal cancer experience more deterioration in health-related quality of life than younger patients during the first year of palliative chemotherapy? A prospective real-world observational study. J Geriatr Oncol. 2024 Apr;15(3):101715. doi: 10.1016/j.jgo.2024.101715. Epub 2024 Feb 15.

    PMID: 38359528DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stein Kaasa, MD PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 23, 2015

Study Start

September 1, 2014

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

NO(7)