COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

NCT ID: NCT00297791

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1044 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

surgery (open or laparoscopic) and observation

Group Type: OTHER

surgery

Intervention Type: PROCEDURE

randomized to open or laparoscopic technique

Interventions

surgery

randomized to open or laparoscopic technique

Intervention Type: PROCEDURE

Other Intervention Names

observation following intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaap Bonjer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University, and VUMC, the Netherlands

Marius Hoogerboord

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Universitair Ziekenjuis Leuven

Leuven, , Belgium

Royal Alexandra Hospital, University of Alberta

Edmonton, Alberta, Canada

CDHA/ Dalhousie University

Halifax, Nova Scotia, Canada

University of Western Ontario

London, Ontario, Canada

Aalborg Hospital

Aalborg, , Denmark

SVS Esbjerg

Esbjerg, , Denmark

Amtssygehus i Gentofte

Gentofte Municipality, , Denmark

Hilleröd Hospital

Hilleröd, , Denmark

Odense Universitetshospital

Odense, , Denmark

Roskilde Hospital

Roskilde, , 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

Wuerzburg University

Würzburg, , Germany

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

VU Medisch Centrum

Amsterdam, , Netherlands

Rijnland Ziekenhuis

Leiderdorp, , Netherlands

Erasmus Medical Centre

Rotterdam, , Netherlands

Medisch Centrum Rijnmond-Zuid

Rotterdam, , Netherlands

Jagiellonian University

Krakow, , Poland

Korea University Anam Hospital

Seoul, , South Korea

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

Sahlgrenska University Hospital

Gothenburg, , Sweden

Örebro Hospital

Örebro, , Sweden

Kärnsjukhuset

Skvöde, , Sweden

Ersta Hospital

Stockholm, , Sweden

Uddevalla Hospital

Uddevalla, , Sweden

Countries

Belgium; Canada; Denmark; Germany; Netherlands; Poland; South Korea; Spain; Sweden

References

Andersson J, Angenete E, Gellerstedt M, Haglind E. Developing a multivariable prediction model of global health-related quality of life in patients treated for rectal cancer: a prospective study in five countries. Int J Colorectal Dis. 2024 Mar 5;39(1):35. doi: 10.1007/s00384-024-04605-y.

Reference Type: DERIVED

PMID: 38441657 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32224742 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29746337 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25830422 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24924798 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23640671 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23395398 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19486621 (View on PubMed)

Other Identifiers

CDHA007

Identifier Type: -

Identifier Source: org_study_id