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

Nova Scotia Health Authority (NSHA)

Status and phase

Completed

Phase 3

Conditions

Rectal Cancer

Treatments

Procedure: surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00297791

CDHA007

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,044 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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