COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer.

BACKGROUND Laparoscopic surgery has proven to be safe and effective. However, the value of laparoscopic resection for malignancy in terms of cancer outcome can only be assessed by large prospective randomized clinical trials with sufficient follow-up. METHODS COLOR (COlon carcinoma Laparoscopic or Open Resection) is a European multicenter randomized trial that began in 1997. In 27 hospitals in Sweden, The Netherlands, Germany, France, Italy, Spain, and the United Kingdom, 1200 patients will be included. The primary endpoint of the study is cancer-free survival after 3 years. RESULTS In <3.5 YEARS, >850 patients have been randomized for right hemicolectomy (47%), left hemicolectomy (11%), and sigmoidectomy (42%). Fifty seven patients were excluded after randomization. Forty six months after the start of the trial, the overall recurrence rate is 6.8%. The distribution of stage of disease is as follows: stage I, 25%; stage II, 41%; stage III, 32%; stage IV, 2%. CONCLUSION Although laparoscopic surgery appears to be of value in the treatment of colorectal cancer, the final, results of randomized trials need to be considered to determine its definitive role. Given the current accrual rate, the COLOR study will be completed in 2002.