COLOR II: Laparoscopic Versus Open Rectal Cancer Removal | NCT00297791

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Apr 2013Actual

Completion Date

Sep 2015Actual

First Submitted Date

Feb 27, 2006

First Submission Date that Met QC Criteria

Feb 27, 2006

First Posted Date

Mar 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,044Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	surgery (open or laparoscopic) and observation	Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	randomized to open or laparoscopic technique	1	observation following intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
locoregional recurrence rate		3 years post operatively

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaap Bonjer, MD, PhD	Dalhousie University, and VUMC, the Netherlands	Principal Investigator
Marius Hoogerboord	Nova Scotia Health Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenjuis Leuven		Leuven			Belgium
Royal Alexandra Hospital, University of Alberta

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38441657	Derived	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.
32224742	Derived

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases