Rectal Cancer
Conditions
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
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.
Interventions
PROCEDUREsurgery
randomized to open or laparoscopic technique
Sponsors
Nova Scotia Health Authority
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| locoregional recurrence rate | 3 years post operatively |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | three, five and seven years post-operatively |
| port-site and wound-site recurrences | annually for seven years |
| distant metastases rate | annually for seven years |
| operative mortality and morbidity | 8 week or in-hospital |
| macroscopic evaluation of the resected specimen | post-operative |
| survival free of cancer recurrence | three, five and seven years post-operatively |
| duration of absence of work | 8 weeks and 6 months post-operatively |
| postoperative health related quality of life,including standardized questionnaires on sexual and bladder function | weekly for 8 weeks |
| in-hospital direct and indirect costs | seven years |
| out-of-hospital postoperative costs | seven years |
| duration of in-hospital stay | post-operative |
Countries
Belgium, Canada, Denmark, Germany, Netherlands, Poland, South Korea, Spain, Sweden
Outcome results
None listed