Randomized clinical trials in rectal and anal cancer

Treatment of rectal cancer has changed dramatically over the past two decades. Radical surgery alone for resectable rectal cancer has been replaced by combined modality therapy. Interest in optimizing sphincter preservation and quality of life motivated surgeons to seek less radical surgery without compromising oncologic principles. The treatment of advanced colorectal cancer has long been a dilemma for clinicians. After many years of therapy limited to 5-fluorouracil (5-FU)-based chemotherapy, a number of new discoveries have significantly advanced this field in the last decade. The advent of irinotecan has given us hope for a second line chemotherapeutic agent and a possible new combination for first line chemotherapy.