Trial Information

Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

Preoperative chemoradiation has become a standard part of treatment protocols in stage II
and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of
preoperative application of chemotherapeutics and irradiation includes improved compliance,
reduced toxicity and downstaging of the tumour in a substantial number of patients. The
latter may enhance the rate of curative surgery, permit sphincter preservation in patients
with low-sited tumours and have a positive impact on the quality of life of these patients.
Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland)
mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more
patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may
further enhance its efficacy and tolerability, offering the potential for an enhanced
therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and
toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally
advanced rectal cancer. The primary endpoint of the study is a pathologically determined
complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of
sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival
parameters will be analysed.