COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

• 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 ]

• survival free of cancer recurrence at three, five and seven years
• overall survival at three, five and seven years
• port-site and wound-site recurrences
• distant metastases rate
• 8 week or in-hospital operative mortality and morbidity
• macroscopic evaluation of the resected specimen
• duration of in-hospital stay post-operatively
• duration of absence of work
• postoperative health related quality of life,including standardized questionnaires on sexual and bladder function
• in-hospital direct and indirect costs
• out-of-hospital postoperative costs

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.

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.

• 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.

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