Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Dietmar Oefner, MD
Principal Investigator
Austrian Breast & Colorectal Cancer Study Group
Austria: Federal Ministry for Health and Women
ABCSG 95 / TAKO 05
NCT00297141
October 2004
March 2006
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