Working… Menu
Trial record 1 of 1 for:    colofol
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Nordic Cancer Union
Danish Cancer Society
Danish Colorectal Cancer Group
Information provided by (Responsible Party):
Peer Wille-Jørgensen, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: CT-scan, CEA, X-ray of lungs Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: 1 frequent control
Follow-up 6, 12, 18, 24 and 36 months after surgery
Procedure: CT-scan, CEA, X-ray of lungs
Arm 1: 6, 12, 18, 24 and 36 months after surgery

2 less frequent control
Follow-up 12 and 36 months after surgery
Procedure: CT-scan, CEA, X-ray of lungs
Arm 2: 12 and 36 months after surgery

Primary Outcome Measures :
  1. Overall and cancer-specific mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life. Cost-effectiveness of follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225641

Layout table for location information
Peer Wille-Jørgensen
Copenhagen, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Nordic Cancer Union
Danish Cancer Society
Danish Colorectal Cancer Group
Layout table for investigator information
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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Peer Wille-Jørgensen, Peer Wille-Jørgensen, DMSc, Bispebjerg Hospital Identifier: NCT00225641    
Other Study ID Numbers: COLOFOL
Danish Cancer Union 56 100 306
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Peer Wille-Jørgensen, Bispebjerg Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases