title: Randomized controlled trial of postoperative radiotherapy and short-term time-scheduled 5-fluorouracil against surgery alone in the treatment of Dukes B and C rectal cancer. Norwegian Adjuvant Rectal Cancer Project Group.
abstract: BACKGROUND
  The purpose of the present study was to investigate whether a 1-month regimen of postoperative radiotherapy combined with 5-fluorouracil could reduce the local recurrence rate and improve survival in patients with Dukes B and C rectal cancer.
  
  
  METHODS
  One hundred and forty-four patients were randomized to surgery alone or surgery combined with postoperative radiotherapy (46 Gy) and bolus 5-fluorouracil 30 min before six of the radiotherapy fractions. One hundred and thirty-six patients were eligible.
  
  
  RESULTS
  The adjuvant treatment was well tolerated. After an observation time of 4-8 years, patients in the adjuvant treatment group had a cumulative local recurrence rate of 12 per cent compared with 30 per cent in the group that had surgery only (P = 0.01). The 5-year recurrence-free and overall survival rate was 64 per cent in the adjuvant group compared with 46 per cent (P = 0.01) and 50 per cent (P = 0.05) respectively in the surgery group. The adjusted relative risk of recurrence and death for the adjuvant group was 0.48 (95 per cent confidence interval 0.28-0.82) and 0.56 (0.33-0.94) respectively.
  
  
  CONCLUSIONS
  The 1-month postoperative combination regimen improved treatment results in patients with Dukes B and C rectal cancer, in terms of local recurrence rate, recurrence-free survival and overall survival, without serious side-effects.
authors.affiliation: Norwegian Radium Hospital, Oslo, Norway.
authors.forename: K M
authors.initials: KM
authors.lastname: Tveit
authors.forename: I
authors.initials: I
authors.lastname: Guldvog
authors.forename: S
authors.initials: S
authors.lastname: Hagen
authors.forename: E
authors.initials: E
authors.lastname: Trondsen
authors.forename: T
authors.initials: T
authors.lastname: Harbitz
authors.forename: K
authors.initials: K
authors.lastname: Nygaard
authors.forename: J B
authors.initials: JB
authors.lastname: Nilsen
authors.forename: E
authors.initials: E
authors.lastname: Wist
authors.forename: E
authors.initials: E
authors.lastname: Hannisdal
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D011182:Postoperative Care; D011878:Radiotherapy / Q000009:adverse effects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil