title: Promising results of a cooperative group phase II trial of preoperative chemoradiation for locally advanced rectal cancer (TROG 9801).
abstract: OBJECTIVE
  This article reports the overall survival, failure-free survival, local failure, and late radiation toxicity of a phase II trial of preoperative radiotherapy with continuous infusion 5-fluorouracil for rectal cancer after a minimum 3.5 years of follow-up.
  
  
  METHODS
  Eligible patients were those with newly diagnosed localized adenocarcinoma of the rectum, within 12 cm of the anal verge, staged T3-T4 and deemed suitable for curative resection. Radiotherapy (50.4 Gy in 28 fractions in five weeks and three days) was given with continuous infusion 5-fluorouracil throughout the course of radiotherapy.
  
  
  RESULTS
  A total of 82 patients were accrued in 13 months. The median follow-up time was 4.1 (range, 2.3-4.5) years. There were 55 males (67 percent) and the median age was 59 (range, 27-87) years. Patients were staged pretreatment as T3 (89 percent) and resectable T4 (11 percent). Endorectal ultrasound was performed in 70 percent and magnetic resonance imaging in another 5 percent. The four-year overall and failure-free survival rates were 82 percent (95 percent CI: 72-89) and 69 percent (95 percent CI: 58-78), respectively. The cumulative incidence of local failure at four years was 3.9 percent (95 percent CI: 1.3-11). Risk of failures, local and distant, has not reached a plateau phase.
  
  
  CONCLUSIONS
  This regimen can be delivered safely and without leading to a significant increase in late toxicity. It provides excellent local control and favorable overall survival. There is a need for longer follow-up than has commonly been used for the proper evaluation of failures after an effective regimen of preoperative chemoradiation.
authors.affiliation: Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. Sam.Ngan@petermac.org
authors.forename: Samuel Y K
authors.initials: SY
authors.lastname: Ngan
authors.forename: Richard
authors.initials: R
authors.lastname: Fisher
authors.forename: Bryan H
authors.initials: BH
authors.lastname: Burmeister
authors.forename: John
authors.initials: J
authors.lastname: Mackay
authors.forename: David
authors.initials: D
authors.lastname: Goldstein
authors.forename: Andrew
authors.initials: A
authors.lastname: Kneebone
authors.forename: David
authors.initials: D
authors.lastname: Schache
authors.forename: David
authors.initials: D
authors.lastname: Joseph
authors.forename: Joseph
authors.initials: J
authors.lastname: McKendrick
authors.forename: Trevor
authors.initials: T
authors.lastname: Leong
authors.forename: Beverley
authors.initials: B
authors.lastname: McClure
authors.forename: Danny
authors.initials: D
authors.lastname: Rischin
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D005472:Fluorouracil