Neoplasms, ColorectalNCT02395224
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
An observational study of Neoplasms, Colorectal and Neoplasm Metastasis, run by Norwegian University of Science and Technology at 7 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Colorectal, Neoplasm Metastasis
- What is being tested?
- cancer treatment and follow-up according to current regional and national guidelines
- How many people
- 354 participants
- Where
- 7 sitesNorway
- Study dates
- Sep 2014to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosis of metastatic colorectal cancer treated with a curative or non-curative intention, or local disease not treated with a curative intention.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Ålesund Hospital
Ålesund
Kristiansund Hospital
Kristiansund
Levanger Hospital
Levanger
Molde hospital
Molde
Namsos Hospital
Namsos
St Olavs Hospital
Trondheim
Volda Hospital HF
Volda, N-6100
About this study
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.
Read the 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.
- Conditions
- Neoplasms, Colorectal, Neoplasm Metastasis
- Being tested
- cancer treatment and follow-up according to current regional and national guidelines
- Keywords
- Follow-up studies, Prognosis, Palliative care, Chemotherapy, adjuvant, Cost-benefit analysis, Population, Antineoplastic agents/Adverse effects, Terminal care, Medical futility, Survival rate, Norway
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cancer treatment and follow-up according to current regional and national guidelinesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Cancer-specific and overall survival according to treatment, age, sex, biological markers
Measured: 3 years or until death
Secondary outcomes (6)
Nutritional status
reported on PG-SGA, patient version
Measured: 3 years or until death
Patient expectations
patient expectations about effects of chemotherapy and satisfaction with treatment
Measured: 3 years or until death
WHO performance status
Measured: 3 years or until death
Toxicity of therapy
Number of dose reductions and treatment delays
Measured: 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
Measured: 3 years or until death
Health related quality of life
reported on EORTC QLQ-C30
Measured: 3 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startSep 2014
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, ColorectalStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395224
- Sponsor's protocol ID
- 2013/1361
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2015
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hatlevoll I, Kristensen AK, Solheim TS, Elvebakken H, Salvesen O, Oldervoll LM, Wibe A, Hofsli E. Do older patients with colorectal cancer experience more deterioration in health-related quality of life than younger patients during the first year of palliative chemotherapy? A prospective real-world observational study. J Geriatr Oncol. 2024 Apr;15(3):101715. doi: 10.1016/j.jgo.2024.101715. Epub 2024 Feb 15.
PubMed 38359528
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
- ClinicalTrials.gov ID
- NCT02395224
- Acronym / sponsor ID
- 2013/1361
- Conditions
- Neoplasms, Colorectal, Neoplasm Metastasis
- Keywords
- Follow-up studies, Prognosis, Palliative care, Chemotherapy, adjuvant, Cost-benefit analysis, Population, Antineoplastic agents/Adverse effects, Terminal care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge
- Study start
- Sep 2014 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosis of metastatic colorectal cancer treated with a curative or non-curative intention, or local disease not treated with a curative intention.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cancer treatment and follow-up according to current regional and national guidelines | Other | – |
Primary outcome
survival
Time frame: 3 years or until death
Cancer-specific and overall survival according to treatment, age, sex, biological markers
6 secondary outcomes
Nutritional status
Time frame: 3 years or until death
Patient expectations
Time frame: 3 years or until death
WHO performance status
Time frame: 3 years or until death
Toxicity of therapy
Time frame: 3 years or until death
Toxicity of therapy
Time frame: 3 years or until death
Health related quality of life
Time frame: 3 years or until death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 38359528Hatlevoll I, Kristensen AK, Solheim TS, Elvebakken H, Salvesen O, Oldervoll LM, Wibe A, Hofsli E. Do older patients with colorectal cancer experience more deterioration in health-related quality of life than younger patients during the first year of palliative chemotherapy? A prospective real-world observational study. J Geriatr Oncol. 2024 Apr;15(3):101715. doi: 10.1016/j.jgo.2024.101715. Epub 2024 Feb 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Kaasa, MD PhD study director
Norwegian University of Science and Technology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Colorectal and Neoplasm Metastasis, run by Norwegian University of Science and Technology at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 3 years or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.