NCT00297791

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,044

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_3

Geographic Reach
9 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 21, 2024

Status Verified

July 1, 2013

Enrollment Period

8.8 years

First QC Date

February 27, 2006

Last Update Submit

August 19, 2024

Conditions

Rectal Cancer

Keywords

rectal cancerlaparoscopic techniqueopen techniqueclinical trialmulticenter studyrandomized controlled trialTumor Below 15cmcurative surgical resectionno evidence for distant metastases

Outcome Measures

Primary Outcomes (1)

  • locoregional recurrence rate

    3 years post operatively

Secondary Outcomes (11)

  • survival free of cancer recurrence

    three, five and seven years post-operatively

  • overall survival

    three, five and seven years post-operatively

  • port-site and wound-site recurrences

    annually for seven years

  • distant metastases rate

    annually for seven years

  • operative mortality and morbidity

    8 week or in-hospital

  • +6 more secondary outcomes

Study Arms (1)

1

OTHER

surgery (open or laparoscopic) and observation

Procedure: surgery

Interventions

surgeryPROCEDURE

randomized to open or laparoscopic technique

Also known as: observation following intervention
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Universitair Ziekenjuis Leuven

Leuven, Belgium

Location

Royal Alexandra Hospital, University of Alberta

Edmonton, Alberta, Canada

Location

CDHA/ Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

University of Western Ontario

London, Ontario, Canada

Location

Aalborg Hospital

Aalborg, Denmark

Location

SVS Esbjerg

Esbjerg, Denmark

Location

Amtssygehus i Gentofte

Gentofte Municipality, Denmark

Location

Hilleröd Hospital

Hilleröd, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

Viborg

Viborg, Denmark

Location

Ludwig-Maximilians Universität Klinikum Großhadern

München, Germany

Location

Caritas-Krankenhaus St. Josef

Regensburg, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Marienhospital

Stuttgart, Germany

Location

Wuerzburg University

Würzburg, Germany

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

VU Medisch Centrum

Amsterdam, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Medisch Centrum Rijnmond-Zuid

Rotterdam, Netherlands

Location

Jagiellonian University

Krakow, Poland

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Hospital Clinic i Provencial de Barcelona

Barcelona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital S.A.S. de Jerez

Cadiz, Spain

Location

Hospital del Sureste de Madrid

Madrid, Spain

Location

Arrixaca Hospital Universitario

Murcia, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Örebro Hospital

Örebro, Sweden

Location

Kärnsjukhuset

Skvöde, Sweden

Location

Ersta Hospital

Stockholm, Sweden

Location

Uddevalla Hospital

Uddevalla, Sweden

Location

Related Publications (8)

  • 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.

    PMID: 38441657DERIVED

  • 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.

    PMID: 32224742DERIVED

  • 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.

    PMID: 29746337DERIVED

  • 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.

    PMID: 25830422DERIVED

  • 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.

    PMID: 24924798DERIVED

  • 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.

    PMID: 23640671DERIVED

  • 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.

    PMID: 23395398DERIVED

  • 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.

    PMID: 19486621DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jaap Bonjer, MD, PhD

    Dalhousie University, and VUMC, the Netherlands

    PRINCIPAL INVESTIGATOR

  • Marius Hoogerboord

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

June 1, 2004

Primary Completion

April 1, 2013

Study Completion

September 1, 2015

Last Updated

August 21, 2024

Record last verified: 2013-07

Locations

SE(5)BE(1)CA(3)KR(1)DE(5)NL(7)DK(7)ES(5)PL(1)