Colorectal CancerNCT00225641
Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer
A study testing CT-scan, CEA, X-ray of lungs in people with Colorectal Cancer, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim is to conduct a prospective multicentre randomised study comparing two different control regimens after resection for colorectal cancer stage II - III. Follow-up after surgery for colorectal cancer is a controversial issue. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CT-scan, CEA, X-ray of lungs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Dec 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radical surgery (R0-resection) for colorectal adenocarcinoma - with or without adjuvant treatment
- Age < 75 years
- Provision of written informed consent for participation
- "Clean colon" verified by perioperative barium enema or colonoscopy last 3 months post-surgery
- Tumour stage: II-III (Tany N1-2 M0, T3-4NanyM0, Dukes´ B - C)
Who cannot join
- A clinical diagnosis of HNPCC (non hereditary polyposis colorectal cancer) or FAP (familial polyposis coli)
- Local resection for colorectal cancer (e.g., TEM-procedure)
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis)
- Inability to provide informed consent or refusal to do so
- Inability to comply with the control or intense follow-up program
- Participation in other clinical trials interfering with the control-programs
- Previous malignancies (except for non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COLOFOL - A Pragmatic Study to Assess the Frequency of Surveillance Tests After Curative Resection in Patients With Stage II and III Colorectal Cancer - a Randomised Multicentre Trial
The aim is to conduct a prospective multicentre randomised study comparing two different control regimens after resection for colorectal cancer stage II - III. Follow-up after surgery for colorectal cancer is a controversial issue. The reasons for follow-up are: to obtain a better overall survival, for scientific purposes and/or for psychological reasons and/or as quality assessment. Meta-analyses of randomised controlled studies have lately shown that a beneficial effect on the overall mortality could be found with intense follow-up compared to sporadic. This study compares the regimen of CT-scan or MR scan of the liver, control of the carcinoembryonic antigen (CEA), and CT-scan or X-ray of the lungs in two groups with either control after 12 and 36 months, or after 6, 12, 18, 24, and 36 months. The efficacy parameters are total and cancer-specific mortality.
Read the detailed description
The aim is to investigate the efficiency of two follow-up programs after radical surgery for colorectal cancer. Colorectal cancer attacks between 3-5% of the European population during their lifetime, and about 75% of these will have potential curative surgery performed. Follow up after surgery is costly and time consuming for both patients and the Health Care Systems. The intensity of follow up as well as the methods employed vary tremendously from center to centre and from country to country. Until recently the scientific documentation for the cost-effectiveness of follow-up was very sparse, but recent compiling of data indicates that intense follow up can save lives as compared to sporadic follow-up at an acceptable cost. However, the optimal follow-up intervals and the best methods are unknown. Previous results indicate that scanning of the liver and measuring of the tumor-marker CEA may be a way forward. A prospective randomised multicenter study in centers from Denmark (approx. 15), Sweden (approx. 20), Poland (approx. 6), Hungary (approx. 2) and perhaps The Netherlands and UK is starting in 2005 after basic work with protocols, ethical committees now has been finished. This basic work was supported by the Nordic Cancer Union with a grant of 25,000 EUROS. The patients will be randomised to follow-up with CEA, multislice CT scan of the liver and X-ray of the lungs, either 12 and 36 months after surgery or 6, 12, 18, 24 and 36 months after surgery. If recurrence is detected, the patient will be offered the best available treatment either as repeated surgery with curative intent or palliative oncological treatment. Data will be collected electronically via the internet to an already constructed database. The primary efficacy parameter is 3 and 5 years overall and cancer-specific survival. It is planned that recruitment will be at least 2,500 patients, which is feasible in 2 years.
- Conditions
- Colorectal Cancer
- Being tested
- CT-scan, CEA, X-ray of lungs
- Keywords
- Follow-up
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scan, CEA, X-ray of lungsProcedure or surgery
Arm 1: 6, 12, 18, 24 and 36 months after surgery
CT-scan, CEA, X-ray of lungsProcedure or surgery
Arm 2: 12 and 36 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 frequent control | Active comparator | Follow-up 6, 12, 18, 24 and 36 months after surgery Receives: Procedure: CT-scan, CEA, X-ray of lungs |
| 2 less frequent control | Other | Follow-up 12 and 36 months after surgery Receives: Procedure: CT-scan, CEA, X-ray of lungs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall and cancer-specific mortality
Measured: 5 years
Secondary outcomes (1)
Quality of life. Cost-effectiveness of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startMar 2006
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Cancer Union, Danish Cancer Society, Danish Colorectal Cancer Group
- Responsible party
- Principal investigator, Peer Wille-Jørgensen, Bispebjerg Hospital
- Investigators
- Peer Wille-Jørgensen, Ass Prof., Principal investigator, Bispebjerg Hospital, DenmarkAdam Dziki, Principal investigator, Medical University of Lodz, PolandNils Lundqvist, Principal investigator, Norrtälje Hospital, SwedenMichael Goldinger, Principal investigator, St.Görans Hospital, Stockholm, SwedenMats Bragmark, Principal investigator, Danderyd Hospital, Stockholm, SwedenUlrik Lindforss, MD Phd, Principal investigator, Södertälje Hospital, SwedenKennet Smedh, Principal investigator, Central Hospital, Västerås, SwedenMonika Svanfeldt, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225641
- Sponsor's protocol ID
- COLOFOL
- Other IDs
- Danish Cancer Union 56 100 306
- Status last verified
- Dec 2015
- First submitted
- 22 Sep 2005
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorensen HT, Horvath-Puho E, Petersen SH, Wille-Jorgensen P, Syk I; COLOFOL Study Group. More vs Less Frequent Follow-Up Testing and 10-Year Mortality in Patients With Stage II or III Colorectal Cancer: Secondary Analysis of the COLOFOL Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446243. doi: 10.1001/jamanetworkopen.2024.46243.
PubMed 39570590Wille-Jorgensen P, Syk I, Smedh K, Laurberg S, Nielsen DT, Petersen SH, Renehan AG, Horvath-Puho E, Pahlman L, Sorensen HT; COLOFOL Study Group. Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer-Specific Mortality in Patients With Stage II or III Colorectal Cancer: The COLOFOL Randomized Clinical Trial. JAMA. 2018 May 22;319(20):2095-2103. doi: 10.1001/jama.2018.5623.
PubMed 29800179
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLOFOL - A Pragmatic Study to Assess the Frequency of Surveillance Tests After Curative Resection in Patients With Stage II and III Colorectal Cancer - a Randomised Multicentre Trial
- ClinicalTrials.gov ID
- NCT00225641
- Acronym / sponsor ID
- COLOFOL
- Conditions
- Colorectal Cancer
- Keywords
- Follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Nordic Cancer Union, Danish Cancer Society, Danish Colorectal Cancer Group
- Study start
- Mar 2006
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Sep 2005 (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 aim is to conduct a prospective multicentre randomised study comparing two different control regimens after resection for colorectal cancer stage II - III. Follow-up after surgery for colorectal cancer is a controversial issue. The reasons for follow-up are: to obtain a better overall survival, for scientific purposes and/or for psychological reasons and/or as quality assessment. Meta-analyses of randomised controlled studies have lately shown that a beneficial effect on the overall mortality could be found with intense follow-up compared to sporadic. This study compares the regimen of CT-scan or MR scan of the liver, control of the carcinoembryonic antigen (CEA), and CT-scan or X-ray of the lungs in two groups with either control after 12 and 36 months, or after 6, 12, 18, 24, and 36 months. The efficacy parameters are total and cancer-specific mortality.
Detailed description
The aim is to investigate the efficiency of two follow-up programs after radical surgery for colorectal cancer. Colorectal cancer attacks between 3-5% of the European population during their lifetime, and about 75% of these will have potential curative surgery performed. Follow up after surgery is costly and time consuming for both patients and the Health Care Systems. The intensity of follow up as well as the methods employed vary tremendously from center to centre and from country to country. Until recently the scientific documentation for the cost-effectiveness of follow-up was very sparse, but recent compiling of data indicates that intense follow up can save lives as compared to sporadic follow-up at an acceptable cost. However, the optimal follow-up intervals and the best methods are unknown. Previous results indicate that scanning of the liver and measuring of the tumor-marker CEA may be a way forward. A prospective randomised multicenter study in centers from Denmark (approx. 15), Sweden (approx. 20), Poland (approx. 6), Hungary (approx. 2) and perhaps The Netherlands and UK is starting in 2005 after basic work with protocols, ethical committees now has been finished. This basic work was supported by the Nordic Cancer Union with a grant of 25,000 EUROS. The patients will be randomised to follow-up with CEA, multislice CT scan of the liver and X-ray of the lungs, either 12 and 36 months after surgery or 6, 12, 18, 24 and 36 months after surgery. If recurrence is detected, the patient will be offered the best available treatment either as repeated surgery with curative intent or palliative oncological treatment. Data will be collected electronically via the internet to an already constructed database. The primary efficacy parameter is 3 and 5 years overall and cancer-specific survival. It is planned that recruitment will be at least 2,500 patients, which is feasible in 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 frequent control | Active comparator | Procedure: CT-scan, CEA, X-ray of lungsFollow-up 6, 12, 18, 24 and 36 months after surgery |
| 2 less frequent control | Other | Procedure: CT-scan, CEA, X-ray of lungsFollow-up 12 and 36 months after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radical surgery (R0-resection) for colorectal adenocarcinoma - with or without adjuvant treatment
- Age < 75 years
- Provision of written informed consent for participation
- "Clean colon" verified by perioperative barium enema or colonoscopy last 3 months post-surgery
- Tumour stage: II-III (Tany N1-2 M0, T3-4NanyM0, Dukes´ B - C)
Key exclusion criteria (7 listed)
- A clinical diagnosis of HNPCC (non hereditary polyposis colorectal cancer) or FAP (familial polyposis coli)
- Local resection for colorectal cancer (e.g., TEM-procedure)
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis)
- Inability to provide informed consent or refusal to do so
- Inability to comply with the control or intense follow-up program
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 |
|---|---|---|
| CT-scan, CEA, X-ray of lungsArm 1: 6, 12, 18, 24 and 36 months after surgery | Procedure or surgery | 1 frequent control |
| CT-scan, CEA, X-ray of lungsArm 2: 12 and 36 months after surgery | Procedure or surgery | 2 less frequent control |
Primary outcome
Overall and cancer-specific mortality
Time frame: 5 years
1 secondary outcome
Quality of life. Cost-effectiveness of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 39570590Sorensen HT, Horvath-Puho E, Petersen SH, Wille-Jorgensen P, Syk I; COLOFOL Study Group. More vs Less Frequent Follow-Up Testing and 10-Year Mortality in Patients With Stage II or III Colorectal Cancer: Secondary Analysis of the COLOFOL Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446243. doi: 10.1001/jamanetworkopen.2024.46243.
- Derived from this study: PubMed 29800179Wille-Jorgensen P, Syk I, Smedh K, Laurberg S, Nielsen DT, Petersen SH, Renehan AG, Horvath-Puho E, Pahlman L, Sorensen HT; COLOFOL Study Group. Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer-Specific Mortality in Patients With Stage II or III Colorectal Cancer: The COLOFOL Randomized Clinical Trial. JAMA. 2018 May 22;319(20):2095-2103. doi: 10.1001/jama.2018.5623.
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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.
Peer Wille-Jørgensen, Ass Prof. principal investigator
Bispebjerg Hospital, Denmark
Adam Dziki principal investigator
Medical University of Lodz, Poland
Nils Lundqvist principal investigator
Norrtälje Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-scan, CEA, X-ray of lungs in people with Colorectal Cancer, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 7 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Overall and cancer-specific mortality (time frame: 5 years). 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 NCT00225641, which also lists 2 linked publications.
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 22 Dec 2015.