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

• ClinicalTrials.gov Identifier: NCT00225641
• Recruitment Status: Unknown
• First Posted: September 26, 2005
• Last Update Posted: December 22, 2015
• Sponsor: Bispebjerg Hospital
• Collaborators: Nordic Cancer Union; Danish Cancer Society; Danish Colorectal Cancer Group
• Information provided by (Responsible Party): Peer Wille-Jørgensen, Bispebjerg Hospital

Tracking Information

• First Submitted Date: September 22, 2005
• First Posted Date: September 26, 2005
• Last Update Posted Date: December 22, 2015
• Study Start Date: March 2006
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 28, 2007): Overall and cancer-specific mortality [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: September 23, 2005): Overall and cancer-specific mortality
• Current Secondary Outcome Measures (submitted: September 23, 2005): Quality of life. Cost-effectiveness of follow-up
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

• Procedure: CT-scan, CEA, X-ray of lungs
  Arm 1: 6, 12, 18, 24 and 36 months after surgery
• Procedure: CT-scan, CEA, X-ray of lungs
  Arm 2: 12 and 36 months after surgery

Study Arms

• Active Comparator: 1 frequent control
  Follow-up 6, 12, 18, 24 and 36 months after surgery
  Intervention: Procedure: CT-scan, CEA, X-ray of lungs
• 2 less frequent control
  Follow-up 12 and 36 months after surgery
  Intervention: Procedure: CT-scan, CEA, X-ray of lungs

• Publications *: Wille-Jørgensen P, Syk I, Smedh K, Laurberg S, Nielsen DT, Petersen SH, Renehan AG, Horváth-Puhó E, Påhlman L, Sørensen 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 23, 2005): 2500
• Original Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00225641
• Other Study ID Numbers: COLOFOL; Danish Cancer Union 56 100 306
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Peer Wille-Jørgensen, Bispebjerg Hospital
• Study Sponsor: Bispebjerg Hospital

Collaborators

• Nordic Cancer Union
• Danish Cancer Society
• Danish Colorectal Cancer Group

Investigators

• Principal Investigator: Peer Wille-Jørgensen, Ass Prof.; Bispebjerg Hospital, Denmark
• Principal Investigator: Adam Dziki; Medical University of Lodz, Poland
• Principal Investigator: Nils Lundqvist; Norrtälje Hospital, Sweden
• Principal Investigator: Michael Goldinger; St.Görans Hospital, Stockholm, Sweden
• Principal Investigator: Mats Bragmark; Danderyd Hospital, Stockholm, Sweden
• Principal Investigator: Ulrik Lindforss, MD Phd; Södertälje Hospital, Sweden
• Principal Investigator: Kennet Smedh; Central Hospital, Västerås, Sweden
• Principal Investigator: Monika Svanfeldt; Karolinska University Hospital
• Principal Investigator: Johan Ottoson; Central Hospital, Kristianstad, Sweden
• Principal Investigator: Anna Martling; Karolinska University Hospital, Solna, Sweden
• Principal Investigator: Jonas Bengtson; Sahlgrenska University Hospital, Gothenburg, Sweden
• Principal Investigator: Birger Sandzén; University Hospital of Umeå, Sweden
• Principal Investigator: Ingvar Syk; Malmö Academic Hospital, Sweden
• Principal Investigator: Lars Påhlman; Uppsala University Academic Hospital, Sweden
• Principal Investigator: Pamela Buchwald; Helsingborg Hospital, Sweden
• Principal Investigator: Erling Østergaard; Viborg Hospital, Denmark
• Principal Investigator: Per Andersen; Fyn Hospital, Svendborg, Denmark
• Principal Investigator: Mogens Madsen; Herning Hospital, Denmark
• Principal Investigator: Karl Erik Jensen; Esbjerg Hospital, Denmark
• Principal Investigator: Per Gandrup; Aalborg Hospital, Denmark
• Principal Investigator: Per Jess; Hillerød hospital, Denmark
• Principal Investigator: Henrik Christensen; Aarhus Hospital, Denmark
• Principal Investigator: Luis Carriquiry; Maciel Hospital, Montevideo, Uruguay
• Principal Investigator: Jósef Kladny; Pomeranian Medical University, Poland
• Principal Investigator: Christoffer Odensten; Sunderby Hospital, Luleå, Sweden
• Principal Investigator: Yngve Raab; Södersjukhuset, Stockholm, Sweden
• Principal Investigator: Allan G Pedersen; Randers Hospital, Denmark
• Principal Investigator: Helena Laurell; Mora Hospital, Sweden
• Principal Investigator: Ronan O'Connel; St. Vincents Hospital, Dublin, Ireland

• PRS Account: Bispebjerg Hospital
• Verification Date: December 2015