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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02395224
• Other study ID #: 2013/1361
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 354
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Colorectal

Intervention

Other:
• cancer treatment and follow-up according to current regional and national guidelines

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Kristiansund Hospital	Kristiansund
Norway	Levanger Hospital	Levanger
Norway	Molde hospital	Molde
Norway	Namsos Hospital	Namsos
Norway	St Olavs Hospital	Trondheim
Norway	Volda Hospital HF	Volda

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Midt-Norge

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	Cancer-specific and overall survival according to treatment, age, sex, biological markers	3 years or until death
Secondary	Nutritional status	reported on PG-SGA, patient version	3 years or until death
Secondary	Patient expectations	patient expectations about effects of chemotherapy and satisfaction with treatment	3 years or until death
Secondary	WHO performance status		3 years or until death
Secondary	Toxicity of therapy	Number of dose reductions and treatment delays	3 years or until death
Secondary	Toxicity of therapy	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
Secondary	Health related quality of life	reported on EORTC QLQ-C30	3 years or until death