COLOR II: Laparoscopic Versus Open Rectal Cancer Removal - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rectal Cancer	Procedure: surgery	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:

locoregional recurrence rate [ Time Frame: 3 years post operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

survival free of cancer recurrence [ Time Frame: three, five and seven years post-operatively ] [ Designated as safety issue: No ]
overall survival [ Time Frame: three, five and seven years post-operatively ] [ Designated as safety issue: No ]
port-site and wound-site recurrences [ Time Frame: annually for seven years ] [ Designated as safety issue: No ]
distant metastases rate [ Time Frame: annually for seven years ] [ Designated as safety issue: No ]
operative mortality and morbidity [ Time Frame: 8 week or in-hospital ] [ Designated as safety issue: No ]
macroscopic evaluation of the resected specimen [ Time Frame: post-operative ] [ Designated as safety issue: No ]
duration of in-hospital stay [ Time Frame: post-operative ] [ Designated as safety issue: No ]
duration of absence of work [ Time Frame: 8 weeks and 6 months post-operatively ] [ Designated as safety issue: No ]
postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [ Time Frame: weekly for 8 weeks ] [ Designated as safety issue: No ]
in-hospital direct and indirect costs [ Time Frame: seven years ] [ Designated as safety issue: No ]
out-of-hospital postoperative costs [ Time Frame: seven years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1100
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 surgery (open or laparoscopic) and observation	Procedure: surgery randomized to open or laparoscopic technique Other Name: observation following intervention

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297791

Show 35 Study Locations

Sponsors and Collaborators

Capital District Health Authority, Canada

Investigators

Principal Investigator:

Jaap Bonjer, MD, PhD

Dalhousie University, CDHA and VUMC, the Netherlands

More Information

No publications provided by Capital District Health Authority, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Dan Med Bull. 2009 May;56(2):89-91.

Responsible Party:	Dr. Jaap Bonjer, Captial District Health Authority, Dalhousie University, VUMC-the Netherlands
ClinicalTrials.gov Identifier:	NCT00297791 History of Changes
Other Study ID Numbers:	CDHA007
Study First Received:	February 27, 2006
Last Updated:	February 10, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:

rectal cancer
laparoscopic technique
open technique
clinical trial
multicenter study

randomized controlled trial
Tumor Below 15cm
curative surgical resection
no evidence for distant metastases

Additional relevant MeSH terms:

Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013