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

Danish Colorectal Cancer Group

Information provided by (Responsible Party):

Peer Wille-Jørgensen, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT00225641

First received: September 22, 2005

Last updated: December 21, 2015

Last verified: December 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

September 22, 2005

Last Updated Date

December 21, 2015

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall and cancer-specific mortality [ Time Frame: 5 years ]

Original Primary Outcome Measures ^ICMJE

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

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Active, not recruiting

Estimated Enrollment ^ICMJE

2500

Estimated 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

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

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

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