Clinical trial · Interventional
Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-scan, CEA, X-ray of lungs | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 frequent control
- description
- Follow-up 6, 12, 18, 24 and 36 months after surgery
- interventionNames
- Procedure: CT-scan, CEA, X-ray of lungs
- type
- OTHER
- label
- 2 less frequent control
- description
- Follow-up 12 and 36 months after surgery
- interventionNames
- Procedure: CT-scan, CEA, X-ray of lungs
Primary outcomes (1)
- measure
- Overall and cancer-specific mortality
- timeFrame
- 5 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDSorensen 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. PMID 39570590
- DERIVEDWille-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. PMID 29800179