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

NCT ID: NCT00225641

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Keywords

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Follow-up

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 frequent control

Follow-up 6, 12, 18, 24 and 36 months after surgery

Group Type ACTIVE_COMPARATOR

CT-scan, CEA, X-ray of lungs

Intervention Type PROCEDURE

Arm 1: 6, 12, 18, 24 and 36 months after surgery

2 less frequent control

Follow-up 12 and 36 months after surgery

Group Type OTHER

CT-scan, CEA, X-ray of lungs

Intervention Type PROCEDURE

Arm 2: 12 and 36 months after surgery

Interventions

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CT-scan, CEA, X-ray of lungs

Arm 1: 6, 12, 18, 24 and 36 months after surgery

Intervention Type PROCEDURE

CT-scan, CEA, X-ray of lungs

Arm 2: 12 and 36 months after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Cancer Union

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Danish Colorectal Cancer Group

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peer Wille-Jørgensen

Peer Wille-Jørgensen, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peer Wille-Jørgensen, Ass Prof.

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, Denmark

Adam Dziki

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz, Poland

Nils Lundqvist

Role: PRINCIPAL_INVESTIGATOR

Norrtälje Hospital, Sweden

Michael Goldinger

Role: PRINCIPAL_INVESTIGATOR

St.Görans Hospital, Stockholm, Sweden

Mats Bragmark

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital, Stockholm, Sweden

Ulrik Lindforss, MD Phd

Role: PRINCIPAL_INVESTIGATOR

Södertälje Hospital, Sweden

Kennet Smedh

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Västerås, Sweden

Monika Svanfeldt

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Johan Ottoson

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Kristianstad, Sweden

Anna Martling

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital, Solna, Sweden

Jonas Bengtson

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Birger Sandzén

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Umeå, Sweden

Ingvar Syk

Role: PRINCIPAL_INVESTIGATOR

Malmö Academic Hospital, Sweden

Lars Påhlman

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Academic Hospital, Sweden

Pamela Buchwald

Role: PRINCIPAL_INVESTIGATOR

Helsingborg Hospital, Sweden

Erling Østergaard

Role: PRINCIPAL_INVESTIGATOR

Viborg Hospital, Denmark

Per Andersen

Role: PRINCIPAL_INVESTIGATOR

Fyn Hospital, Svendborg, Denmark

Mogens Madsen

Role: PRINCIPAL_INVESTIGATOR

Herning Hospital, Denmark

Karl Erik Jensen

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Hospital, Denmark

Per Gandrup

Role: PRINCIPAL_INVESTIGATOR

Aalborg Hospital, Denmark

Per Jess

Role: PRINCIPAL_INVESTIGATOR

Hillerød hospital, Denmark

Henrik Christensen

Role: PRINCIPAL_INVESTIGATOR

Aarhus Hospital, Denmark

Luis Carriquiry

Role: PRINCIPAL_INVESTIGATOR

Maciel Hospital, Montevideo, Uruguay

Jósef Kladny

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University, Poland

Christoffer Odensten

Role: PRINCIPAL_INVESTIGATOR

Sunderby Hospital, Luleå, Sweden

Yngve Raab

Role: PRINCIPAL_INVESTIGATOR

Södersjukhuset, Stockholm, Sweden

Allan G Pedersen

Role: PRINCIPAL_INVESTIGATOR

Randers Hospital, Denmark

Helena Laurell

Role: PRINCIPAL_INVESTIGATOR

Mora Hospital, Sweden

Ronan O'Connel

Role: PRINCIPAL_INVESTIGATOR

St. Vincents Hospital, Dublin, Ireland

Locations

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Peer Wille-Jørgensen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Sorensen HT, Horvath-Puho E, Petersen SH, Wille-Jorgensen P, Syk I; COLOFOL Study Group. More vs Less Frequent Follow-Up Testing and 10-Year Mortality in Patients With Stage II or III Colorectal Cancer: Secondary Analysis of the COLOFOL Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446243. doi: 10.1001/jamanetworkopen.2024.46243.

Reference Type DERIVED
PMID: 39570590 (View on PubMed)

Wille-Jorgensen P, Syk I, Smedh K, Laurberg S, Nielsen DT, Petersen SH, Renehan AG, Horvath-Puho E, Pahlman L, Sorensen 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.

Reference Type DERIVED
PMID: 29800179 (View on PubMed)

Other Identifiers

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Danish Cancer Union 56 100 306

Identifier Type: -

Identifier Source: secondary_id

COLOFOL

Identifier Type: -

Identifier Source: org_study_id