title: Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer.
abstract: OBJECTIVE
  To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.
  
  
  METHODS
  One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.
  
  
  RESULTS
  After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.
  
  
  CONCLUSIONS
  Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.
authors.affiliation: Department of Radiotherapy, University of Erlangen-Nürnberg, Erlangen, Germany. claus.roedel@strahlen.med.uni-erlangen.de
authors.forename: Claus
authors.initials: C
authors.lastname: Rödel
authors.forename: Torsten
authors.initials: T
authors.lastname: Liersch
authors.forename: Robert Michael
authors.initials: RM
authors.lastname: Hermann
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
authors.forename: Thomas
authors.initials: T
authors.lastname: Reese
authors.forename: Matthias
authors.initials: M
authors.lastname: Hipp
authors.forename: Alois
authors.initials: A
authors.lastname: Fürst
authors.forename: Nimrod
authors.initials: N
authors.lastname: Schwella
authors.forename: Michael
authors.initials: M
authors.lastname: Bieker
authors.forename: Gunter
authors.initials: G
authors.lastname: Hellmich
authors.forename: Hermann
authors.initials: H
authors.lastname: Ewald
authors.forename: Jörg
authors.initials: J
authors.lastname: Haier
authors.forename: Florian
authors.initials: F
authors.lastname: Lordick
authors.forename: Michael
authors.initials: M
authors.lastname: Flentje
authors.forename: Heiko
authors.initials: H
authors.lastname: Sülberg
authors.forename: Werner
authors.initials: W
authors.lastname: Hohenberger
authors.forename: Rolf
authors.initials: R
authors.lastname: Sauer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000627:therapeutic use*; D000077150:Oxaliplatin; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil