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

NCT00225641 | Unknown DMC

• 2 other identifiers: COLOFOLDanish Cancer Union 56 100 306
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Follow-up

Outcome Measures

Primary Outcomes (1)

• Overall and cancer-specific mortality

  5 years

Secondary Outcomes (1)

• Quality of life. Cost-effectiveness of follow-up

Study Arms (2)

1 frequent control

ACTIVE COMPARATOR

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

Procedure: CT-scan, CEA, X-ray of lungs

2 less frequent control

OTHER

Follow-up 12 and 36 months after surgery

Procedure: CT-scan, CEA, X-ray of lungs

Interventions

CT-scan, CEA, X-ray of lungs PROCEDURE

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

1 frequent control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Nordic Cancer Union: collaborator
• Danish Cancer Society: collaborator
• Danish Colorectal Cancer Group: collaborator

Study Sites (1)

Peer Wille-Jørgensen

Copenhagen, DK-2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 39570590 DERIVED

• 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.

  PMID: 29800179 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peer Wille-Jørgensen, DMSc

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: March 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

DK (1)