| September 22, 2005
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| September 26, 2005
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| December 22, 2015
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| March 2006
|
| December 2015 (Final data collection date for primary outcome measure)
|
| Overall and cancer-specific mortality [ Time Frame: 5 years ]
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| Overall and cancer-specific mortality
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| Complete list of historical versions of study NCT00225641 on ClinicalTrials.gov Archive Site
|
| Quality of life. Cost-effectiveness of follow-up
|
| Same as current
|
| Not Provided
|
| Not Provided
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| |
| Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer |
| 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. |
| 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. |
| Interventional |
| Not Provided |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Colorectal Cancer |
- Procedure: CT-scan, CEA, X-ray of lungs
Arm 1: 6, 12, 18, 24 and 36 months after surgery
- Procedure: CT-scan, CEA, X-ray of lungs
Arm 2: 12 and 36 months after surgery
|
- Active Comparator: 1 frequent control
Follow-up 6, 12, 18, 24 and 36 months after surgery
Intervention: Procedure: CT-scan, CEA, X-ray of lungs
- 2 less frequent control
Follow-up 12 and 36 months after surgery
Intervention: Procedure: CT-scan, CEA, X-ray of lungs
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| Not Provided |
| |
| Active, not recruiting |
| 2500 |
| December 2015 |
| December 2015 (Final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 75 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Denmark |
| |
| |
| NCT00225641 |
COLOFOL
Danish Cancer Union 56 100 306 |
| Yes |
| Not Provided |
| Not Provided |
| Peer Wille-Jørgensen, Bispebjerg Hospital |
| Bispebjerg Hospital |
- Nordic Cancer Union
- Danish Cancer Society
- Danish Colorectal Cancer Group
|
| Principal Investigator: |
Peer Wille-Jørgensen, Ass Prof. |
Bispebjerg Hospital, Denmark |
| Principal Investigator: |
Adam Dziki |
Medical University of Lodz, Poland |
| Principal Investigator: |
Nils Lundqvist |
Norrtälje Hospital, Sweden |
| Principal Investigator: |
Michael Goldinger |
St.Görans Hospital, Stockholm, Sweden |
| Principal Investigator: |
Mats Bragmark |
Danderyd Hospital, Stockholm, Sweden |
| Principal Investigator: |
Ulrik Lindforss, MD Phd |
Södertälje Hospital, Sweden |
| Principal Investigator: |
Kennet Smedh |
Central Hospital, Västerås, Sweden |
| Principal Investigator: |
Monika Svanfeldt |
Karolinska University Hospital |
| Principal Investigator: |
Johan Ottoson |
Central Hospital, Kristianstad, Sweden |
| Principal Investigator: |
Anna Martling |
Karolinska University Hospital, Solna, Sweden |
| Principal Investigator: |
Jonas Bengtson |
Sahlgrenska University Hospital, Gothenburg, Sweden |
| Principal Investigator: |
Birger Sandzén |
University Hospital of Umeå, Sweden |
| Principal Investigator: |
Ingvar Syk |
Malmö Academic Hospital, Sweden |
| Principal Investigator: |
Lars Påhlman |
Uppsala University Academic Hospital, Sweden |
| Principal Investigator: |
Pamela Buchwald |
Helsingborg Hospital, Sweden |
| Principal Investigator: |
Erling Østergaard |
Viborg Hospital, Denmark |
| Principal Investigator: |
Per Andersen |
Fyn Hospital, Svendborg, Denmark |
| Principal Investigator: |
Mogens Madsen |
Herning Hospital, Denmark |
| Principal Investigator: |
Karl Erik Jensen |
Esbjerg Hospital, Denmark |
| Principal Investigator: |
Per Gandrup |
Aalborg Hospital, Denmark |
| Principal Investigator: |
Per Jess |
Hillerød Hospital, Denmark |
| Principal Investigator: |
Henrik Christensen |
Aarhus Hospital, Denmark |
| Principal Investigator: |
Luis Carriquiry |
Maciel Hospital, Montevideo, Uruguay |
| Principal Investigator: |
Jósef Kladny |
Pomeranian Medical University, Poland |
| Principal Investigator: |
Christoffer Odensten |
Sunderby Hospital, Luleå, Sweden |
| Principal Investigator: |
Yngve Raab |
Södersjukhuset, Stockholm, Sweden |
| Principal Investigator: |
Allan G Pedersen |
Randers Hospital, Denmark |
| Principal Investigator: |
Helena Laurell |
Mora Hospital, Sweden |
| Principal Investigator: |
Ronan O'Connel |
St. Vincents Hospital, Dublin, Ireland |
|
| Bispebjerg Hospital |
| December 2015 |
