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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms, Colorectal, Neoplasm Metastasis

Intervention / Treatment
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* Other: cancer treatment and follow-up according to current regional and national guidelines


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cancer treatment and follow-up according to current regional and national guidelines|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | Cancer-specific and overall survival according to treatment, age, sex, biological markers | 3 years or until death | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Antineoplastic agents/Adverse effects, Medical futility, Survival rate, Norway, Follow-up studies, Prognosis, Chemotherapy, adjuvant, Cost-benefit analysis, Population, Terminal care