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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 10/2007

Open Access 01-10-2007 | Gastrointestinal Oncology

Preoperative Chemoradiotherapy with Capecitabine and Oxaliplatin in Locally Advanced Rectal Cancer. A Phase I–II Multicenter Study of the Dutch Colorectal Cancer Group

Authors: Geke A. Hospers, Cornelis J. A. Punt, Margot E. Tesselaar, Annemieke Cats, Klaas Havenga, Jan W. H. Leer, Corrie A. Marijnen, Edwin P. Jansen, Han H. J. M. Van Krieken, Theo Wiggers, Cornelis J. H. Van de Velde, Nanno H. Mulder

Published in: Annals of Surgical Oncology | Issue 10/2007

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Abstract

Background

We studied the maximum tolerated dose (MTD) and efficacy of oxaliplatin added to capecitabine and radiotherapy (Capox-RT) as neoadjuvant therapy for rectal cancer.

Methods

T3-4 rectal cancer patients received escalating doses of oxaliplatin (day 1 and 29) with a fixed dose of capecitabine of 1000 mg/m2 twice daily (days 1–14, 25–38) added to RT with 50.4 Gy and surgery after 6–8 weeks. The MTD, determined during phase I, was used in the subsequent phase II, in which R0 resection rate (a negative circumferential resection margin) was the primary end point.

Results

Twenty-one patients were evaluable. In the phase I part, oxaliplatin at 85 mg/m2 was established as MTD. In phase II, the main toxicity was grade III diarrhea (18%). All patients underwent surgery, and 20 patients had a resectable tumor. An R0 was achieved in 17/21 patients, downstaging to T0-2 in 7/21 and a pCR in 2/21.

Conclusion

Combination of Capox-RT has an acceptable acute toxicity profile and a high R0 resection rate of 81% in locally advanced rectal cancer. However the pCR rate was low.
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Metadata
Title
Preoperative Chemoradiotherapy with Capecitabine and Oxaliplatin in Locally Advanced Rectal Cancer. A Phase I–II Multicenter Study of the Dutch Colorectal Cancer Group
Authors
Geke A. Hospers
Cornelis J. A. Punt
Margot E. Tesselaar
Annemieke Cats
Klaas Havenga
Jan W. H. Leer
Corrie A. Marijnen
Edwin P. Jansen
Han H. J. M. Van Krieken
Theo Wiggers
Cornelis J. H. Van de Velde
Nanno H. Mulder
Publication date
01-10-2007
Publisher
Springer-Verlag
Published in
Annals of Surgical Oncology / Issue 10/2007
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-007-9396-6

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