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

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ClinicalTrials.gov Identifier: NCT00225641
Recruitment Status : Unknown
Verified December 2015 by Peer Wille-Jørgensen, Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2005
Last Update Posted : December 22, 2015
Sponsor:
Collaborators:
Nordic Cancer Union
Danish Cancer Society
Danish Colorectal Cancer Group
Information provided by (Responsible Party):
Peer Wille-Jørgensen, Bispebjerg Hospital

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 * Wille-Jørgensen P, Syk I, Smedh K, Laurberg S, Nielsen DT, Petersen SH, Renehan AG, Horváth-Puhó E, Påhlman L, Sørensen 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.

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP