Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited. The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
chemotherapy oral use
chemotherapy intravenous use
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
Paracelsus Medical University Salzburg - Oncology
Salzburg, State of Salzburg, Austria
Medical University of Vienna, Radiotherapy
Rate of T-downstaging (Reduction of the T-stadium)
surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Time frame: at the time of final surgery
Evaluation of the toxicity grade III and IV of the therapy scheme
from Visit 1 till surgery: weekly visits (visit 1 to visit 5) followed by final examination (performed 1 to 2 weeks after visit 5) before surgery followed by hospital admission (performed 1 to 2 weeks after final examination) followed by surgery ((performed 1 to 2 weeks after hospital admission)
Time frame: week 1 to max. week 10
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Vienna, State of Vienna, Austria
Medical University of Graz, Oncology
Graz, Styria, Austria
State Hospital Leoben, Surgery
Leoben, Styria, Austria
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria