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Prospective phase II trial of neoadjuvant chemo-radiotherapy with Oxaliplatin and Capecitabine in locally advanced rectal cancer (XELOXART)

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Abstract

Neo-adjuvant chemo-radiotherapy (CT–RT) has been shown to decrease local recurrence rate in locally advanced rectal cancer. This multicenter phase II trial was conducted to evaluate the feasibility, safety and effectiveness of a combination of pre-operative radiotherapy and concurrent Capecitabine plus Oxaliplatin (XELOXART Trial). From October 2008 to May 2011, fifty consecutive patients affected with T3/T4 and/or N+ rectal cancer were enrolled. Treatment protocol consisted of 50.4 Gy in 28 fractions, Oxaliplatin 60 mg/m2 once a week for 6 weeks and oral Capecitabine 825 mg/m2 twice daily from day 1 to 14 and from day 22 to 35. Surgery was planned 6–8 weeks after. Main endpoints were pathological complete response rate (pCR) and the type of surgery performed compared to the planned one at diagnosis. 50 patients were included; pCR (ypT0N0M0) was achieved in 6 patients (12 %). Tumour downstaging was observed in 27 patients (54 %), and nodal downstaging in 32 patients (64 %). A total of 32 patients had lower rectal cancer, with 24 candidate for abdominal-perineal resection. At the end of CT–RT, a total of 12/24 (50 %) underwent conservative surgery. Grade 3 toxicity (fatigue and diarrhoea) occurred in 4 % of patients; grade 4 sensory neuropathy occurred in 2 % of patients. Perioperative complications of any grade occurred in 10 % of patients. Pre-operative CT–RT with Capecitabine-Oxaliplatin was well tolerated and resulted in an encouraging sphincter preservation and tumour downstaging rate. No improvements in terms of pathological complete response rate were shown.

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Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Oncology, Radiation Oncology, University of Torino, via Genova 3, 10126, Turin, Italy

    Umberto Ricardi, Pierfrancesco Franco, Fernando Munoz, Nadia Rondi & Andrea Riccardo Filippi

  2. Medical Oncology 1, University Hospital Città della Salute e della Scienza di Torino, c.so Bramante 88, 1026, Turin, Italy

    Patrizia Racca, Laura Fanchini & Libero Ciuffreda

  3. Medical Oncology, ASL TO 5, Turin, Italy

    Vincenzo Dongiovanni

  4. Radiation Oncology, Institute for Cancer Research and Treatment, strada provinciale 142, Km 3,95, Candiolo, TO, Italy

    Pietro Gabriele

  5. Department of Life Sciences and Human Oncology, Pathology, University of Torino, via Santena 7, 1026, Turin, Italy

    Paola Cassoni

  6. Department of Surgical Sciences, Digestive, Colorectal, Oncologic, and Minimally Invasive Surgery, University of Torino, c.so Bramante 88, Turin, Italy

    Mario Morino

  7. Medical Oncology, Institute for Cancer Research and Treatment, strada Provinciale 142, Km 3,95, Candiolo, TO, Italy

    Massimo Aglietta

  8. Rete Oncologica del Piemonte-Valle d’Aosta, Turin, Italy

    Oscar Bertetto

Authors
  1. Umberto Ricardi
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  2. Patrizia Racca
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  3. Pierfrancesco Franco
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  4. Fernando Munoz
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  5. Laura Fanchini
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  6. Nadia Rondi
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  7. Vincenzo Dongiovanni
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  8. Pietro Gabriele
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  9. Paola Cassoni
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  10. Libero Ciuffreda
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  11. Mario Morino
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  12. Andrea Riccardo Filippi
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  13. Massimo Aglietta
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  14. Oscar Bertetto
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Corresponding author

Correspondence to Andrea Riccardo Filippi.

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Ricardi, U., Racca, P., Franco, P. et al. Prospective phase II trial of neoadjuvant chemo-radiotherapy with Oxaliplatin and Capecitabine in locally advanced rectal cancer (XELOXART). Med Oncol 30, 581 (2013). https://doi.org/10.1007/s12032-013-0581-0

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  • DOI: https://doi.org/10.1007/s12032-013-0581-0

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