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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Active 18 to 75 Other COLOFOL Danish Cancer Union 56 100 306, NCT00225641

Trial Description

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.

Further Study Information

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 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Bispebjerg Hospital

Peer Wille-Jørgensen, Ass Prof.

Principal Investigator

Adam Dziki

Principal Investigator

Nils Lundqvist

Principal Investigator

Michael Goldinger

Principal Investigator

Mats Bragmark

Principal Investigator

Ulrik Lindforss, MD Phd

Principal Investigator

Kennet Smedh

Principal Investigator

Monika Svanfeldt

Principal Investigator

Johan Ottoson

Principal Investigator

Anna Martling

Principal Investigator

Jonas Bengtson

Principal Investigator

Birger Sandzén

Principal Investigator

Ingvar Syk

Principal Investigator

Lars Påhlman

Principal Investigator

Hans Rahr

Principal Investigator

Erling Østergaard

Principal Investigator

Per Andersen

Principal Investigator

Mogens Madsen

Principal Investigator

Karl Erik Jensen

Principal Investigator

Per Gandrup

Principal Investigator

Per Jess

Principal Investigator

Henrik Christensen

Principal Investigator

Luis Carriquiry

Principal Investigator

Jósef Kladny

Principal Investigator

Christoffer Odensten

Principal Investigator

Yngve Raab

Principal Investigator

Allan G Pedersen

Principal Investigator

Helena Laurell

Principal Investigator

Peer Wille-Jørgensen, Ass Prof.		Ph: 45-3531-3086
		Email: pwj01@bbh.regionh.dk

Denmark
	Copenhagen
	Peer Wille-Jørgensen
		Peer Wille-Jørgensen, As. Prof	Ph: 45-3531-3086
			Email: pwj01@bbh.regionh.dk
		Peer Wille-Jørgensen, As Prof	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00225641
Information obtained from ClinicalTrials.gov on October 23, 2008