Abstract
BackgroundThe additional use of radiotherapy has changed the treatment of locally advanced rectal cancer (LARC) dramatically. But a major achievement has been the development of total mesorectal excision (TME) as a surgical standard and the recognition that the surgeon is the predominant prognostic factor. The benefit of preoperative hypofractionated radiotherapy (SCRT; five fractions each of 5 Gy), initially established by the Swedish Rectal Cancer Trial, has been demonstrated in conjunction with TME by the Dutch Colorectal Cancer Group. The concept of combined neoadjuvant radiochemotherapy (conventional radiation of about 50 Gy with chemotherapy) has not been compared over surgery alone with TME. However, the German Rectal Cancer Study Group recently demonstrated that preoperative radiochemotherapy (RCT) was better than postoperative radiochemotherapy in terms of local control.Methods and designPatients with histological proven rectal cancer staged T2N+ or T3 are randomized to receive either SCRT (25 Gy in five fractions of 5 Gy) plus TME-surgery within 5 days or RCT (50.4 Gy in 28 fractions of 1.8 Gy, continuous infusion 5-fluorouracil) plus TME-surgery 4–6 weeks later. All patients receive adjuvant chemotherapy (12 weeks continuous infusional 5-FU) and are followed up for 5 years. TME-quality is independently documented by the surgeon and the pathologist. Hypothesis of the study is that RCT is superior to SCRT in terms of local recurrence after five years. Secondary endpoints are overall survival, disease-free survival, complete resection rate (R0 resection), rate of sphincter saving resection, acute and late toxicity (radiation related side effects), and quality of life (including long term bowel function).DiscussionSimilar long-term survival, local control and late morbidity have been reported for both concepts of preoperative therapy in non-comparative studies. In addition to other ongoing (and recently published) comparative trials we include a larger number of patients for adequate power, apply quality-controlled TME and try to avoid the adjuvant treatment bias by mandatory adjuvant chemotherapy in both groups. Further more, stratification of the initially planned surgical procedure and sphincter-preservation will generate valid evidence whether RCT will allow a less aggressive (sphincter saving) surgical approach.
Highlights
The additional use of radiotherapy has changed the treatment of locally advanced rectal cancer (LARC) dramatically
In addition to other ongoing comparative trials we include a larger number of patients for adequate power, apply quality-controlled total mesorectal excision (TME) and try to avoid the adjuvant treatment bias by mandatory adjuvant chemotherapy in both groups
short-course radiotherapy (SCRT) with TME was superior to TME alone in terms of local recurrence, whereas overall survival was similar in both groups [4]
Summary
The additional use of radiotherapy has changed the treatment of locally advanced rectal cancer (LARC) dramatically. The benefit of preoperative hypofractionated radiotherapy (SCRT; five fractions each of 5 Gy), initially established by the Swedish Rectal Cancer Trial, has been demonstrated in conjunction with TME by the Dutch Colorectal Cancer Group. The German Rectal Cancer Study Group recently demonstrated that preoperative radiochemotherapy (RCT) was better than postoperative radiochemotherapy in terms of local control. The Swedish Rectal Cancer Trial, evaluating preoperative short-course radiotherapy (SCRT), found an advantage in overall survival compared to surgery alone [5]. A major achievement in the treatment of LARC has been the development of total mesorectal excision (TME) as a surgical standard [7]. The only study evaluating preoperative therapy together with a documented quality controlled TME-surgery is the Dutch Colorectal Cancer Group study. The EORTC 22921 trial, already started in the late nineties of the last century and published recently, showed a similar reduction in local recurrence whether 5FU/leucovorin chemotherapy was given with pre-operative radiotherapy, after preoperative radiotherapy plus surgery, or both [8]
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