COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: surgery

• Registration Number: NCT00297791
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

Detailed Description

The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.

If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.

Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-03-01
• Primary Completion: 2013-04
• Status Verified: 2013-07
• Study Completion: 2015-09
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

Inclusion Criteria

• solitary rectal cancer observed at colonoscopy or on barium X-ray
• no evidence of distant metastases
• distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
• suitable for elective surgical resection
• informed consent

Exclusion Criteria

• T1 tumors treated by locl excision
• T4 tumors
• patients under 18 years of age
• signs of acute intestinal obstruction
• more than one colorectal tumor
• Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
• active crohn's or active ulcerative colitis
• scheduled need for other synchronous colon surgery
• preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
• preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
• other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
• absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	surgery	surgery (open or laparoscopic) and observation

Primary Outcome Measures

Name	Time	Method
locoregional recurrence rate	3 years post operatively

Secondary Outcome Measures

Name	Time	Method
overall survival	three, five and seven years post-operatively
duration of in-hospital stay	post-operative
survival free of cancer recurrence	three, five and seven years post-operatively
port-site and wound-site recurrences	annually for seven years
macroscopic evaluation of the resected specimen	post-operative
distant metastases rate	annually for seven years
postoperative health related quality of life,including standardized questionnaires on sexual and bladder function	weekly for 8 weeks
out-of-hospital postoperative costs	seven years
operative mortality and morbidity	8 week or in-hospital
duration of absence of work	8 weeks and 6 months post-operatively
in-hospital direct and indirect costs	seven years

Trial Locations

Locations (35)

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Viborg; 🇩🇰 Viborg, Denmark

Ludwig-Maximilians Universität Klinikum Großhadern; 🇩🇪 München, Germany

Caritas-Krankenhaus St. Josef; 🇩🇪 Regensburg, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Marienhospital; 🇩🇪 Stuttgart, Germany

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Wuerzburg University; 🇩🇪 Wuerzburg, Germany

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Hertogenbosch, Netherlands

Hospital Clinic i Provencial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital S.A.S. de Jerez; 🇪🇸 Cadiz, Spain

Hospital del Sureste de Madrid; 🇪🇸 Madrid, Spain

Arrixaca Hospital Universitario; 🇪🇸 Murcia, Spain

Kärnsjukhuset; 🇸🇪 Skvöde, Sweden

Uddevalla Hospital; 🇸🇪 Uddevalla, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Ersta Hospital; 🇸🇪 Stockholm, Sweden

Örebro Hospital; 🇸🇪 Örebro, Sweden

VU Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

CDHA/ Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

Rijnland Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

Royal Alexandra Hospital, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Jagiellonian University; 🇵🇱 Krakow, Poland

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands

Medisch Centrum Rijnmond-Zuid; 🇳🇱 Rotterdam, Netherlands

Universitair Ziekenjuis Leuven; 🇧🇪 Leuven, Belgium

SVS Esbjerg; 🇩🇰 Esbjerg, Denmark

Amtssygehus i Gentofte; 🇩🇰 Gentofte, Denmark

Hilleröd Hospital; 🇩🇰 Hilleröd, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark