Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer

Tracking Information
First Submitted Date ICMJE	September 22, 2005
First Posted Date ICMJE	September 26, 2005
Last Update Posted Date	December 22, 2015
Study Start Date ICMJE	March 2006
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 28, 2007)	Overall and cancer-specific mortality [ Time Frame: 5 years ]
Original Primary Outcome Measures ICMJE; (submitted: September 23, 2005)	Overall and cancer-specific mortality
Change History	Complete list of historical versions of study NCT00225641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 23, 2005)	Quality of life. Cost-effectiveness of follow-up
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer
Official Title ICMJE	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
Brief 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. 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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Colorectal Cancer
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: September 23, 2005)	2500
Original Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2015
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Denmark
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00225641
Other Study ID Numbers ICMJE	COLOFOL; Danish Cancer Union 56 100 306
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Peer Wille-Jørgensen, Bispebjerg Hospital
Study Sponsor ICMJE	Bispebjerg Hospital
Collaborators ICMJE	Nordic Cancer Union; Danish Cancer Society; Danish Colorectal Cancer Group
Investigators ICMJE	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
PRS Account	Bispebjerg Hospital
Verification Date	December 2015
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