title: Prospective phase II trial of neoadjuvant chemo-radiotherapy with Oxaliplatin and Capecitabine in locally advanced rectal cancer (XELOXART).
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/m(2) once a week for 6 weeks and oral Capecitabine 825 mg/m(2) 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.
authors.affiliation: Department of Oncology, Radiation Oncology, University of Torino, via Genova 3, 10126 Turin, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Racca
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Franco
authors.forename: Fernando
authors.initials: F
authors.lastname: Munoz
authors.forename: Laura
authors.initials: L
authors.lastname: Fanchini
authors.forename: Nadia
authors.initials: N
authors.lastname: Rondi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Dongiovanni
authors.forename: Pietro
authors.initials: P
authors.lastname: Gabriele
authors.forename: Paola
authors.initials: P
authors.lastname: Cassoni
authors.forename: Libero
authors.initials: L
authors.lastname: Ciuffreda
authors.forename: Mario
authors.initials: M
authors.lastname: Morino
authors.forename: Andrea Riccardo
authors.initials: AR
authors.lastname: Filippi
authors.forename: Massimo
authors.initials: M
authors.lastname: Aglietta
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D059186:Chemoradiotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D013505:Digestive System Surgical Procedures; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil