Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatment surgery
Phase phase 3
Sponsor Jaap Bonjer
Start date June 2004
End date April 2013
Trial size 1100 participants
Trial identifier NCT00297791, CDHA007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
surgery (open or laparoscopic) and observation
surgery observation following intervention
randomized to open or laparoscopic technique

Primary Outcomes

Measure
locoregional recurrence rate
time frame: 3 years post operatively

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Principal investigator Jaap Bonjer, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Capital District Health Authority, Canada.