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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02395224

Collaborator

Helse Midt-Norge (Other)

354

Enrollment

Locations

100.5

Anticipated Duration (Months)

50.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms, Colorectal Neoplasm Metastasis	Other: cancer treatment and follow-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 Design

Study Type:

Observational

Actual Enrollment :

354 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Outcome Measures

Primary Outcome Measures

survival [3 years or until death]
Cancer-specific and overall survival according to treatment, age, sex, biological markers

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kristiansund Hospital	Kristiansund	Norway
2	Levanger Hospital	Levanger	Norway
3	Molde hospital	Molde	Norway
4	Namsos Hospital	Namsos	Norway
5	St Olavs Hospital	Trondheim	Norway
6	Volda Hospital HF	Volda	Norway	N-6100
7	Ålesund Hospital	Ålesund	Norway