Neoplasm Metastasis Clinical Trial
Official title:
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
Verified date | February 2022 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: - |
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 |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Helse Midt-Norge |
Norway,
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 |
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