title: Neoadjuvant treatment for unresectable rectal cancer: an interim analysis of a multicentre randomized study.
abstract: OBJECTIVE
  To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer.
  
  
  METHODS
  Patients with fixed cT3 or cT4 or locally recurrent rectal cancer without distant metastases were randomized to either 5 × 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment.
  
  
  RESULTS
  49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II.
  
  
  CONCLUSIONS
  The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies.
authors.affiliation: Department of Radiotherapy II, M. Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland. bujko@coi.waw.pl
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bujko
authors.forename: Anna
authors.initials: A
authors.lastname: Nasierowska-Guttmejer
authors.forename: Lucjan
authors.initials: L
authors.lastname: Wyrwicz
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Malinowska
authors.forename: Jacek
authors.initials: J
authors.lastname: Krynski
authors.forename: Ewa
authors.initials: E
authors.lastname: Kosakowska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Rutkowski
authors.forename: Lucyna
authors.initials: L
authors.lastname: Pietrzak
authors.forename: Lucyna
authors.initials: L
authors.lastname: Kepka
authors.forename: Jakub
authors.initials: J
authors.lastname: Radziszewski
authors.forename: Marta
authors.initials: M
authors.lastname: Olszyna-Serementa
authors.forename: Magdalena
authors.initials: M
authors.lastname: Bujko
authors.forename: Anna
authors.initials: A
authors.lastname: Danek
authors.forename: Mariusz
authors.initials: M
authors.lastname: Kryj
authors.forename: Jerzy
authors.initials: J
authors.lastname: Wydmanski
authors.forename: Wojciech
authors.initials: W
authors.lastname: Zegarski
authors.forename: Wlodzimierz
authors.initials: W
authors.lastname: Markiewicz
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Lesniak
authors.forename: Ireneusz
authors.initials: I
authors.lastname: Zygulski
authors.forename: Dorota
authors.initials: D
authors.lastname: Porzuczek-Zuziak
authors.forename: Marek
authors.initials: M
authors.lastname: Bebenek
authors.forename: Adam
authors.initials: A
authors.lastname: Maciejczyk
authors.forename: Wojciech
authors.initials: W
authors.lastname: Polkowski
authors.forename: Beata
authors.initials: B
authors.lastname: Czeremszynska
authors.forename: Ewa
authors.initials: E
authors.lastname: Cieslak-Zeranska
authors.forename: Zygmunt
authors.initials: Z
authors.lastname: Toczko
authors.forename: Andrzej
authors.initials: A
authors.lastname: Radkowski
authors.forename: Leszek
authors.initials: L
authors.lastname: Kolodziejski
authors.forename: Marek
authors.initials: M
authors.lastname: Szczepkowski
authors.forename: Adam
authors.initials: A
authors.lastname: Majewski
authors.forename: Michal
authors.initials: M
authors.lastname: Jankowski
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D012004:Rectal Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil