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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02395224
Enrollment
354
Registered
2015-03-23
Start date
2014-09-30
Completion date
2023-01-15
Last updated
2022-02-14

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

Conditions

Neoplasm Metastasis, Neoplasms, Colorectal

Keywords

Follow-up studies, Prognosis, Palliative care, Chemotherapy, adjuvant, Cost-benefit analysis, Population, Antineoplastic agents/Adverse effects, Terminal care, Medical futility, Survival rate, Norway

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.

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.

Interventions

OTHERcancer treatment and follow-up according to current regional and national guidelines

Sponsors

Helse Midt-Norge
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
survival3 years or until deathCancer-specific and overall survival according to treatment, age, sex, biological markers

Secondary

MeasureTime frameDescription
Nutritional status3 years or until deathreported on PG-SGA, patient version
Patient expectations3 years or until deathpatient expectations about effects of chemotherapy and satisfaction with treatment
WHO performance status3 years or until death
Toxicity of therapy3 years or until deathNumber of dose reductions and treatment delays
Health related quality of life3 years or until deathreported on EORTC QLQ-C30

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026