COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

Rectal Cancer Clinical Trial

— COLORII  

Official title:

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00297791
• Other study ID #: CDHA007
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 27, 2006
• Last updated: July 29, 2013
• Start date: June 2004
• Est. completion date: October 2017

Study information

• Verified date: July 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: October 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• surgery
randomized to open or laparoscopic technique

Locations

Country	Name	City	State
Belgium	Universitair Ziekenjuis Leuven	Leuven
Canada	Royal Alexandra Hospital, University of Alberta	Edmonton	Alberta
Canada	CDHA/ Dalhousie University	Halifax	Nova Scotia
Canada	University of Western Ontario	London	Ontario
Denmark	Aalborg Hospital	Aalborg
Denmark	SVS Esbjerg	Esbjerg
Denmark	Amtssygehus i Gentofte	Gentofte
Denmark	Hilleröd Hospital	Hilleröd
Denmark	Odense Universitetshospital	Odense
Denmark	Roskilde Hospital	Roskilde
Denmark	Viborg	Viborg
Germany	Ludwig-Maximilians Universität Klinikum Großhadern	München
Germany	Caritas-Krankenhaus St. Josef	Regensburg
Germany	University Hospital Regensburg	Regensburg
Germany	Marienhospital	Stuttgart
Germany	Wuerzburg University	Wuerzburg
Korea, Republic of	Korea University Anam Hospital	Seoul
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Jeroen Bosch Ziekenhuis	Hertogenbosch
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	Erasmus Medical Centre	Rotterdam
Netherlands	Medisch Centrum Rijnmond-Zuid	Rotterdam
Poland	Jagiellonian University	Krakow
Spain	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
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Örebro Hospital	Örebro
Sweden	Kärnsjukhuset	Skvöde
Sweden	Ersta Hospital	Stockholm
Sweden	Uddevalla Hospital	Uddevalla

Sponsors (1)

Lead Sponsor	Collaborator
Jaap Bonjer

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Germany,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	locoregional recurrence rate		3 years post operatively	Yes
Secondary	survival free of cancer recurrence		three, five and seven years post-operatively	No
Secondary	overall survival		three, five and seven years post-operatively	No
Secondary	port-site and wound-site recurrences		annually for seven years	No
Secondary	distant metastases rate		annually for seven years	No
Secondary	operative mortality and morbidity		8 week or in-hospital	No
Secondary	macroscopic evaluation of the resected specimen		post-operative	No
Secondary	duration of in-hospital stay		post-operative	No
Secondary	duration of absence of work		8 weeks and 6 months post-operatively	No
Secondary	postoperative health related quality of life,including standardized questionnaires on sexual and bladder function		weekly for 8 weeks	No
Secondary	in-hospital direct and indirect costs		seven years	No
Secondary	out-of-hospital postoperative costs		seven years	No