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Annals of Oncology Advance Access originally published online on October 11, 2005
Annals of Oncology 2005 16(12):1898-1905; doi:10.1093/annonc/mdi406
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© 2005 European Society for Medical Oncology

Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study

J.-P. Machiels1,*, L. Duck1, B. Honhon2, B. Coster2, J.-C. Coche3, P. Scalliet1, Y. Humblet1, S. Aydin1, J. Kerger4, V. Remouchamps5, J.-L. Canon6, P. Van Maele7, L. Gilbeau8, S. Laurent1, C. Kirkove9, M. Octave-Prignot9, J.-F. Baurain1, A. Kartheuser1 and C. Sempoux1

1 Clinique des Pathologies Tumorales du Colon et du Rectum, Centre du Cancer, Université Catholique de Louvain, Brussels; 2 Service d'Oncologie et de Radiothérapie, Hôpital St-Joseph, Gilly; 3 Service de Gastroentérologie, Clinique St-Pierre, Ottignies; 4 Service d'Oncologie, Cliniques Universitaires de Mont-Godinne (UCL) and Clinique St-Elisabeth, Namur; 5 Service de Radiothérapie, Clinique St-Elisabeth, Namur; 6 Service d'Oncologie, Clinique Notre-Dame, Charleroi; 7 Service de Gastroentérologie, Clinique Saint-Jean, Brussels; 8 Service de Radiothérapie, Hôpital de Jolimont, Haine-St-Paul; 9 Service de Radiothérapie, Cliniques Universitaires Saint-Luc, Brussels, Belgium

* Correspondence to: Dr J.-P. Machiels, Medical Oncology Unit, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, 10 avenue Hippocrate, 1200 Brussels, Belgium. Tel: +32-2-764-54-85; Fax: +32-2-764-54-28; E-mail: jean-pascal.machiels{at}onco.ucl.ac.be

Background: Preoperative radiotherapy has been shown to decrease the local recurrence rate of patients with locally advanced rectal cancer. Capecitabine and oxaliplatin are both active anticancer agents in the treatment of patients with advanced colorectal cancer and have radiosensitizing properties. Therefore, these drugs would be expected to improve effectiveness of preoperative radiotherapy in terms of local control and prevention of distant metastases.

Patients and methods: Forty patients with rectal cancer (T3–T4 and/or N+) received radiotherapy (1.8 Gy, 5 days a week over 5 weeks, total dose 45 Gy, 3D conformational technique) in combination with intravenous oxaliplatin 50 mg/m2 once weekly for 5 weeks and oral capecitabine 825 mg/m2 twice daily on each day of radiation. Surgery was performed 6–8 weeks after completion of radiotherapy. The main end points were safety and efficacy as assessed by the pathological complete response (pCR).

Results: The most frequent grade 3/4 adverse event was diarrhea, occurring in 30% of patients. pCR was found in five (14%) patients. According to Dworak's classification, good regression was found in six (18%) additional patients.

Conclusions: Combination of preoperative radiotherapy with capecitabine and oxaliplatin is feasible for downstaging rectal cancer.

Key words: capecitabine, oxaliplatin, preoperative, radiotherapy, rectal cancer


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