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COLOR II: Laparoscopic Versus Open Rectal Cancer Removal (COLORII)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
surgery
Sponsored by
Jaap Bonjer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, laparoscopic technique, open technique, clinical trial, multicenter study, randomized controlled trial, Tumor Below 15cm, curative surgical resection, no evidence for distant metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenjuis Leuven
  • Royal Alexandra Hospital, University of Alberta
  • CDHA/ Dalhousie University
  • University of Western Ontario
  • Aalborg Hospital
  • SVS Esbjerg
  • Amtssygehus i Gentofte
  • Hilleröd Hospital
  • Odense Universitetshospital
  • Roskilde Hospital
  • Viborg
  • Ludwig-Maximilians Universität Klinikum Großhadern
  • Caritas-Krankenhaus St. Josef
  • University Hospital Regensburg
  • Marienhospital
  • Wuerzburg University
  • Korea University Anam Hospital
  • Academisch Medisch Centrum
  • Onze Lieve Vrouwe Gasthuis
  • VU Medisch Centrum
  • Jeroen Bosch Ziekenhuis
  • Rijnland Ziekenhuis
  • Erasmus Medical Centre
  • Medisch Centrum Rijnmond-Zuid
  • Jagiellonian University
  • Hospital Clinic i Provencial de Barcelona
  • Hospital de Sant Pau
  • Hospital S.A.S. de Jerez
  • Hospital del Sureste de Madrid
  • Arrixaca Hospital Universitario
  • Sahlgrenska University Hospital
  • Kärnsjukhuset
  • Ersta Hospital
  • Uddevalla Hospital
  • Örebro Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

surgery (open or laparoscopic) and observation

Outcomes

Primary Outcome Measures

locoregional recurrence rate

Secondary Outcome Measures

survival free of cancer recurrence
overall survival
port-site and wound-site recurrences
distant metastases rate
operative mortality and morbidity
macroscopic evaluation of the resected specimen
duration of in-hospital stay
duration of absence of work
postoperative health related quality of life,including standardized questionnaires on sexual and bladder function
in-hospital direct and indirect costs
out-of-hospital postoperative costs

Full Information

First Posted
February 27, 2006
Last Updated
July 29, 2013
Sponsor
Jaap Bonjer
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1. Study Identification

Unique Protocol Identification Number
NCT00297791
Brief Title
COLOR II: Laparoscopic Versus Open Rectal Cancer Removal
Acronym
COLORII
Official Title
A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jaap Bonjer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
surgery (open or laparoscopic) and observation
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
observation following intervention
Intervention Description
randomized to open or laparoscopic technique
Primary Outcome Measure Information:
Title
locoregional recurrence rate
Time Frame
3 years post operatively
Secondary Outcome Measure Information:
Title
survival free of cancer recurrence
Time Frame
three, five and seven years post-operatively
Title
overall survival
Time Frame
three, five and seven years post-operatively
Title
port-site and wound-site recurrences
Time Frame
annually for seven years
Title
distant metastases rate
Time Frame
annually for seven years
Title
operative mortality and morbidity
Time Frame
8 week or in-hospital
Title
macroscopic evaluation of the resected specimen
Time Frame
post-operative
Title
duration of in-hospital stay
Time Frame
post-operative
Title
duration of absence of work
Time Frame
8 weeks and 6 months post-operatively
Title
postoperative health related quality of life,including standardized questionnaires on sexual and bladder function
Time Frame
weekly for 8 weeks
Title
in-hospital direct and indirect costs
Time Frame
seven years
Title
out-of-hospital postoperative costs
Time Frame
seven years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Bonjer, MD, PhD
Organizational Affiliation
Dalhousie University, and VUMC, the Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marius Hoogerboord
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenjuis Leuven
City
Leuven
Country
Belgium
Facility Name
Royal Alexandra Hospital, University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
CDHA/ Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
Country
Canada
Facility Name
Aalborg Hospital
City
Aalborg
Country
Denmark
Facility Name
SVS Esbjerg
City
Esbjerg
Country
Denmark
Facility Name
Amtssygehus i Gentofte
City
Gentofte
Country
Denmark
Facility Name
Hilleröd Hospital
City
Hilleröd
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
Country
Denmark
Facility Name
Viborg
City
Viborg
Country
Denmark
Facility Name
Ludwig-Maximilians Universität Klinikum Großhadern
City
München
Country
Germany
Facility Name
Caritas-Krankenhaus St. Josef
City
Regensburg
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
Country
Germany
Facility Name
Marienhospital
City
Stuttgart
Country
Germany
Facility Name
Wuerzburg University
City
Wuerzburg
Country
Germany
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
VU Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
Hertogenbosch
Country
Netherlands
Facility Name
Rijnland Ziekenhuis
City
Leiderdorp
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
Country
Netherlands
Facility Name
Medisch Centrum Rijnmond-Zuid
City
Rotterdam
Country
Netherlands
Facility Name
Jagiellonian University
City
Krakow
Country
Poland
Facility Name
Hospital Clinic i Provencial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital S.A.S. de Jerez
City
Cadiz
Country
Spain
Facility Name
Hospital del Sureste de Madrid
City
Madrid
Country
Spain
Facility Name
Arrixaca Hospital Universitario
City
Murcia
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
Kärnsjukhuset
City
Skvöde
Country
Sweden
Facility Name
Ersta Hospital
City
Stockholm
Country
Sweden
Facility Name
Uddevalla Hospital
City
Uddevalla
Country
Sweden
Facility Name
Örebro Hospital
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32224742
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.
Results Reference
derived
PubMed Identifier
29746337
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.
Results Reference
derived
PubMed Identifier
25830422
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.
Results Reference
derived
PubMed Identifier
24924798
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. Erratum In: Br J Surg. 2016 Nov;103(12 ):1746.
Results Reference
derived
PubMed Identifier
23640671
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. Erratum In: Br J Surg. 2016 Nov;103(12 ):1746.
Results Reference
derived
PubMed Identifier
23395398
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.
Results Reference
derived
PubMed Identifier
19486621
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.
Results Reference
derived

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COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

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