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

• Conditions: Neoplasm Metastasis; Neoplasms, Colorectal

• Registration Number: NCT02395224
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-14
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival	3 years or until death	Cancer-specific and overall survival according to treatment, age, sex, biological markers

Secondary Outcome Measures

Name	Time	Method
Nutritional status	3 years or until death	reported on PG-SGA, patient version
WHO performance status	3 years or until death
Health related quality of life	3 years or until death	reported on EORTC QLQ-C30
Toxicity of therapy	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
Patient expectations	3 years or until death	patient expectations about effects of chemotherapy and satisfaction with treatment

Trial Locations

Locations (7)

Namsos Hospital; 🇳🇴 Namsos, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway

Levanger Hospital; 🇳🇴 Levanger, Norway

Volda Hospital HF; 🇳🇴 Volda, Norway

Kristiansund Hospital; 🇳🇴 Kristiansund, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Molde hospital; 🇳🇴 Molde, Norway