Clinical trial NCT00297791: COLOR II: Laparoscopic Versus Open Rectal Cancer Removal
Official title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: rectal cancer
laparoscopic technique
open technique
clinical trial
multicenter study
randomized controlled trial
Tumor Below 15cm
curative surgical resection
no evidence for distant metastases
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: locoregional recurrence rate
timeFrame: 3 years post operatively
Secondary outcomes:
measure: survival free of cancer recurrence
timeFrame: three, five and seven years post-operatively
measure: overall survival
timeFrame: three, five and seven years post-operatively
measure: port-site and wound-site recurrences
timeFrame: annually for seven years
measure: distant metastases rate
timeFrame: annually for seven years
measure: operative mortality and morbidity
timeFrame: 8 week or in-hospital
measure: macroscopic evaluation of the resected specimen
timeFrame: post-operative
measure: duration of in-hospital stay
timeFrame: post-operative
measure: duration of absence of work
timeFrame: 8 weeks and 6 months post-operatively
measure: postoperative health related quality of life,including standardized questionnaires on sexual and bladder function
timeFrame: weekly for 8 weeks
measure: in-hospital direct and indirect costs
timeFrame: seven years
measure: out-of-hospital postoperative costs
timeFrame: seven years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenjuis Leuven
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital, University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: CDHA/ Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Esbjerg
country: Denmark
facility: SVS Esbjerg
city: Gentofte
country: Denmark
facility: Amtssygehus i Gentofte
city: Hilleröd
country: Denmark
facility: Hilleröd Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
city: Viborg
country: Denmark
facility: Viborg
city: München
country: Germany
facility: Ludwig-Maximilians Universität Klinikum Großhadern
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Stuttgart
country: Germany
facility: Marienhospital
city: Wuerzburg
country: Germany
facility: Wuerzburg University
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rijnmond-Zuid
city: Krakow
country: Poland
facility: Jagiellonian University
city: Barcelona
country: Spain
facility: Hospital Clinic i Provencial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Cadiz
country: Spain
facility: Hospital S.A.S. de Jerez
city: Madrid
country: Spain
facility: Hospital del Sureste de Madrid
city: Murcia
country: Spain
facility: Arrixaca Hospital Universitario
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Skvöde
country: Sweden
facility: Kärnsjukhuset
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Örebro
country: Sweden
facility: Örebro Hospital
Study officials:
affiliation: Dalhousie University, and VUMC, the Netherlands
name: Jaap Bonjer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Marius Hoogerboord
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Furst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; on behalf of the COLOR COLOR II study group. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2022 Feb 1;275(2):e420-e427. doi: 10.1097/SLA.0000000000003889.
citation: Petersson J, Koedam TW, Bonjer HJ, Andersson J, Angenete E, Bock D, Cuesta MA, Deijen CL, Furst A, Lacy AM, Rosenberg J, Haglind E; COlorectal cancer Laparoscopic or Open Resection (COLOR) II Study Group. Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II). Ann Surg. 2019 Jan;269(1):53-57. doi: 10.1097/SLA.0000000000002790.
citation: Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
citation: Andersson J, Abis G, Gellerstedt M, Angenete E, Angeras U, Cuesta MA, Jess P, Rosenberg J, Bonjer HJ, Haglind E. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg. 2014 Sep;101(10):1272-9. doi: 10.1002/bjs.9550. Epub 2014 Jun 12.
citation: Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2013 Jun;100(7):941-9. doi: 10.1002/bjs.9144.
citation: van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.
citation: Color II Study Group; Buunen M, Bonjer HJ, Hop WC, Haglind E, Kurlberg G, Rosenberg J, Lacy AM, Cuesta MA, D'Hoore A, Furst A, Lange JF, Jess P, Bulut O, Poornoroozy P, Jensen KJ, Christensen MM, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jager C, Kreis M, van riet Y, van der Harst E, Gerhards MF, Bemelman WA, Hansson BM, Neijenhuis PA, Prins HA, Balague C, Targarona E, Lujan Mompean JA, Franco Osorio JD, Garcia Molina FJ, Skullman S, Lackberg Z, Kressner U, Matthiessen P, Kim SH, Poza AA. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Dan Med Bull. 2009 May;56(2):89-91.