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

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

Interventions

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

Sponsors & Collaborators

• Nordic Cancer Union

  collaborator OTHER

• Danish Cancer Society

  collaborator OTHER

• Danish Colorectal Cancer Group

  collaborator UNKNOWN

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Peer Wille-Jørgensen, Ass Prof. · Bispebjerg Hospital, Denmark

• Adam Dziki · Medical University of Lodz, Poland

• Nils Lundqvist · Norrtälje Hospital, Sweden

• Michael Goldinger · St.Görans Hospital, Stockholm, Sweden

• Mats Bragmark · Danderyd Hospital, Stockholm, Sweden

• Ulrik Lindforss, MD Phd · Södertälje Hospital, Sweden

• Kennet Smedh · Central Hospital, Västerås, Sweden

• Monika Svanfeldt · Karolinska University Hospital

• Johan Ottoson · Central Hospital, Kristianstad, Sweden

• Anna Martling · Karolinska University Hospital, Solna, Sweden

• Jonas Bengtson · Sahlgrenska University Hospital

• Birger Sandzén · University Hospital of Umeå, Sweden

• Ingvar Syk · Malmö Academic Hospital, Sweden

• Lars Påhlman · Uppsala University Academic Hospital, Sweden

• Pamela Buchwald · Helsingborg Hospital, Sweden

• Erling Østergaard · Viborg Hospital, Denmark

• Per Andersen · Fyn Hospital, Svendborg, Denmark

• Mogens Madsen · Herning Hospital, Denmark

• Karl Erik Jensen · Esbjerg Hospital, Denmark

• Per Gandrup · Aalborg Hospital, Denmark

• Per Jess · Hillerød hospital, Denmark

• Henrik Christensen · Aarhus Hospital, Denmark

• Luis Carriquiry · Maciel Hospital, Montevideo, Uruguay

• Jósef Kladny · Pomeranian Medical University, Poland

• Christoffer Odensten · Sunderby Hospital, Luleå, Sweden

• Yngve Raab · Södersjukhuset, Stockholm, Sweden

• Allan G Pedersen · Randers Hospital, Denmark

• Helena Laurell · Mora Hospital, Sweden

• Ronan O'Connel · St. Vincents Hospital, Dublin, Ireland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Denmark

Study Locations