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
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
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
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall and cancer-specific mortality
Outcome Time Frame:
5 years
Principal Investigator
Peer Wille-Jørgensen, Ass Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bispebjerg Hospital, Denmark
Authority:
Sweden: Swedish National Council on Medical Ethics
Study ID:
COLOFOL
NCT ID:
NCT00225641
Start Date:
March 2006
Completion Date:
December 2015
Related Keywords:
- Colorectal Cancer
- Follow-up
- Colorectal Neoplasms
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