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

• ClinicalTrials.gov Identifier: NCT00297791
• Recruitment Status: Unknown
• First Posted: March 1, 2006
• Last Update Posted: July 30, 2013
• Sponsor: Jaap Bonjer
• Information provided by (Responsible Party): Jaap Bonjer, Nova Scotia Health Authority

Tracking Information

• First Submitted Date: February 27, 2006
• First Posted Date: March 1, 2006
• Last Update Posted Date: July 30, 2013
• Study Start Date: June 2004
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 30, 2008): locoregional recurrence rate [ Time Frame: 3 years post operatively ]
• Original Primary Outcome Measures (submitted: February 27, 2006): locoregional recurrence rate 3 years postoperatively

Current Secondary Outcome Measures (submitted: May 30, 2008)

• survival free of cancer recurrence [ Time Frame: three, five and seven years post-operatively ]
• overall survival [ Time Frame: three, five and seven years post-operatively ]
• port-site and wound-site recurrences [ Time Frame: annually for seven years ]
• distant metastases rate [ Time Frame: annually for seven years ]
• operative mortality and morbidity [ Time Frame: 8 week or in-hospital ]
• macroscopic evaluation of the resected specimen [ Time Frame: post-operative ]
• duration of in-hospital stay [ Time Frame: post-operative ]
• duration of absence of work [ Time Frame: 8 weeks and 6 months post-operatively ]
• postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [ Time Frame: weekly for 8 weeks ]
• in-hospital direct and indirect costs [ Time Frame: seven years ]
• out-of-hospital postoperative costs [ Time Frame: seven years ]

Original Secondary Outcome Measures (submitted: February 27, 2006)

• survival free of cancer recurrence at three, five and seven years
• overall survival at three, five and seven years
• port-site and wound-site recurrences
• distant metastases rate
• 8 week or in-hospital operative mortality and morbidity
• macroscopic evaluation of the resected specimen
• duration of in-hospital stay post-operatively
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COLOR II: Laparoscopic Versus Open Rectal Cancer Removal
• Official Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rectal Cancer

Intervention

Procedure: surgery

randomized to open or laparoscopic technique

Other Name: observation following intervention

Study Arms

1

surgery (open or laparoscopic) and observation

Intervention: Procedure: surgery

Publications *

• Koedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Fürst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; COLOR COLOR II study group||. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2020 Mar 27. doi: 10.1097/SLA.0000000000003889. [Epub ahead of print]
• Petersson J, Koedam TW, Bonjer HJ, Andersson J, Angenete E, Bock D, Cuesta MA, Deijen CL, Fürst 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.
• 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.
• Andersson J, Abis G, Gellerstedt M, Angenete E, Angerås 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.
• Andersson J, Angenete E, Gellerstedt M, Angerås U, Jess P, Rosenberg J, Fürst 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.
• van der Pas MH, Haglind E, Cuesta MA, Fürst 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.
• Color II Study Group, Buunen M, Bonjer HJ, Hop WC, Haglind E, Kurlberg G, Rosenberg J, Lacy AM, Cuesta MA, D'Hoore A, Fürst A, Lange JF, Jess P, Bulut O, Poornoroozy P, Jensen KJ, Christensen MM, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jäger C, Kreis M, van riet Y, van der Harst E, Gerhards MF, Bemelman WA, Hansson BM, Neijenhuis PA, Prins HA, Balague C, Targarona E, Luján Mompeán JA, Franco Osorio JD, Garcia Molina FJ, Skullman S, Läckberg 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 1, 2010): 1100
• Original Enrollment (submitted: February 27, 2006): 1275
• Estimated Study Completion Date: October 2017
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Denmark, Germany, Korea, Republic of, Netherlands, Poland, Spain, Sweden
• Removed Location Countries: France, United States

Administrative Information

• NCT Number: NCT00297791
• Other Study ID Numbers: CDHA007
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jaap Bonjer, Nova Scotia Health Authority
• Study Sponsor: Jaap Bonjer
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jaap Bonjer, MD, PhD; Dalhousie University, and VUMC, the Netherlands
• Principal Investigator: Marius Hoogerboord; Nova Scotia Health Authority

• PRS Account: Nova Scotia Health Authority
• Verification Date: July 2013