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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Nordic Cancer Union
Danish Cancer Society
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00225641
First received: September 22, 2005
Last updated: June 22, 2011
Last verified: October 2008
  Purpose

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 Intervention
Colorectal Cancer
Procedure: CT-scan, CEA, X-ray of lungs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

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

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

Estimated Enrollment: 2500
Study Start Date: March 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225641

Locations
Denmark
Peer Wille-Jørgensen
Copenhagen, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Nordic Cancer Union
Danish Cancer Society
Investigators
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, Huddinge, Sweden
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
  More Information

Additional Information:
No publications provided

Responsible Party: Peer Wille-Jørgensen, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00225641     History of Changes
Other Study ID Numbers: COLOFOL, Danish Cancer Union 56 100 306
Study First Received: September 22, 2005
Last Updated: June 22, 2011
Health Authority: Sweden: Swedish National Council on Medical Ethics
Poland: Ministry of Science and Higher Education

Keywords provided by Bispebjerg Hospital:
Follow-up

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 22, 2014