Pre-operative radiochemotherapy with raltitrexed for resectable locally-advanced rectal cancer: A phase II study

Maria Cristina Leonardi, Maria Giulia Zampino, Fabrizio Luca, Barbara Alicja Jereczek-Fossa, Elena Petazzi, Brunilda Tatani, Roberta Lazzari, Roberto Biffi, Katia Lorizzo, Elena Magni, Diego Scanniffio, Franco Orsi, Guido Bonomo, Giuseppe Petralia, Cristina Trovato, Cristiano Crosta, Bruno Andreoni, Roberto Orecchia

Research output: Contribution to journalArticlepeer-review


Background: The aim of the study was to evaluate the response to and toxicity of pre-operative radiochemotherapy containing raltitrexed (Tomudex) for resectable rectal adenocarcinoma. Patients and Methods: From November 2000 to June 2002, 18 consecutive patients staged T3 N0/N+ were treated with pre-operative chemotherapy (3 mg/m 2 of raltitrexed on days 1, 19, 38) and concurrent radiotherapy (RT) (50.4 Gy) in 6 weeks, followed by radical surgery within 8 weeks. Results: The treatment compliance was high. No major acute toxicity was reported. Concerning late toxicity, genitourinary adverse effects were prevalent. A complete response was observed in one patient (6%), partial response in eight (47%), stable disease in seven (41%) and progression in one case. Three-year actuarial disease-free and overall survival rates were 37% and 87.5%, respectively. Conclusion: Raltitrexed did not increase the pathological response rate compared with the rates obtained with use of preoperative RT alone and reported in the literature. Acute morbidity was low and acceptable, while late toxicity was considerable, prevalently concerning sexual dysfunction and urinary complications.

Original languageEnglish
Pages (from-to)2419-2423
Number of pages5
JournalAnticancer Research
Issue number3 B
Publication statusPublished - May 2006


  • Neoadjuvant chemoradiotherapy
  • Raltitrexed
  • Rectal carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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