Prof. Hans de Wilt (Surgery) together with colleagues from LUMC has received a KWF grant for the clinical trial (and its data management) entitled: A randomised Phase II feasibility study to compare radical TME surgery versus preoperative (chemo)radiotherapy and watchful waiting or local excision for treatment of early stage rectal cancer.
At present, patients with early rectal cancer are operated, whereby the rectum is removed and often a temporary or permanent stoma has to be placed. Previous research from this group has shown, that for some patients it is possible to maintain the rectum. Patients do not need a stoma and usually have a better quality of life. The patients having this rectum sparing therapy have to be irradiated, possibly in combination with chemotherapy. After this treatment, the response of the tumor will be assessed to determine whether removal of the rectum is needed or that the tumor can be removed with a local excision of the tumor remnant. Until now a number of studies has been done, which show that in about half of the patients the rectum can be spared. Because these studies have only been done recently, it is not clear if the excellent long-term survival after standard surgery can also be achieved using this organ-sparing approach. Therefore, it is important to examine with which treatment the best results are obtained. In the present trial patients are randomised between the different treatment options and if randomisation is possible a phase III trial will be conducted.
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