Clinical trial NCT00225641: Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Follow-up
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Nordic Cancer Union
name: Danish Cancer Society
name: Danish Colorectal Cancer Group
First posted: 2005-09-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Overall and cancer-specific mortality
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life. Cost-effectiveness of follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Peer Wille-Jørgensen
Study officials:
affiliation: Bispebjerg Hospital, Denmark
name: Peer Wille-Jørgensen, Ass Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Lodz, Poland
name: Adam Dziki
role: PRINCIPAL_INVESTIGATOR
affiliation: Norrtälje Hospital, Sweden
name: Nils Lundqvist
role: PRINCIPAL_INVESTIGATOR
affiliation: St.Görans Hospital, Stockholm, Sweden
name: Michael Goldinger
role: PRINCIPAL_INVESTIGATOR
affiliation: Danderyd Hospital, Stockholm, Sweden
name: Mats Bragmark
role: PRINCIPAL_INVESTIGATOR
affiliation: Södertälje Hospital, Sweden
name: Ulrik Lindforss, MD Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Västerås, Sweden
name: Kennet Smedh
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Monika Svanfeldt
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Kristianstad, Sweden
name: Johan Ottoson
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital, Solna, Sweden
name: Anna Martling
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Jonas Bengtson
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Umeå, Sweden
name: Birger Sandzén
role: PRINCIPAL_INVESTIGATOR
affiliation: Malmö Academic Hospital, Sweden
name: Ingvar Syk
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University Academic Hospital, Sweden
name: Lars Påhlman
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsingborg Hospital, Sweden
name: Pamela Buchwald
role: PRINCIPAL_INVESTIGATOR
affiliation: Viborg Hospital, Denmark
name: Erling Østergaard
role: PRINCIPAL_INVESTIGATOR
affiliation: Fyn Hospital, Svendborg, Denmark
name: Per Andersen
role: PRINCIPAL_INVESTIGATOR
affiliation: Herning Hospital, Denmark
name: Mogens Madsen
role: PRINCIPAL_INVESTIGATOR
affiliation: Esbjerg Hospital, Denmark
name: Karl Erik Jensen
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg Hospital, Denmark
name: Per Gandrup
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillerød hospital, Denmark
name: Per Jess
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus Hospital, Denmark
name: Henrik Christensen
role: PRINCIPAL_INVESTIGATOR
affiliation: Maciel Hospital, Montevideo, Uruguay
name: Luis Carriquiry
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeranian Medical University, Poland
name: Jósef Kladny
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunderby Hospital, Luleå, Sweden
name: Christoffer Odensten
role: PRINCIPAL_INVESTIGATOR
affiliation: Södersjukhuset, Stockholm, Sweden
name: Yngve Raab
role: PRINCIPAL_INVESTIGATOR
affiliation: Randers Hospital, Denmark
name: Allan G Pedersen
role: PRINCIPAL_INVESTIGATOR
affiliation: Mora Hospital, Sweden
name: Helena Laurell
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincents Hospital, Dublin, Ireland
name: Ronan O'Connel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.