title: Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study.
abstract: BACKGROUND
  The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain.
  
  
  METHODS
  One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m(2)/day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2)/day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity.
  
  
  RESULTS
  Overall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1-11.4) and 13 months (8.7-18.1), P = 0.03]. One-year survival was, respectively, 32% and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%).
  
  
  CONCLUSIONS
  This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.
authors.affiliation: Department of Oncology, Anticancer Center G.F. Leclerc, Dijon, France.
authors.forename: B
authors.initials: B
authors.lastname: Chauffert
authors.forename: F
authors.initials: F
authors.lastname: Mornex
authors.forename: F
authors.initials: F
authors.lastname: Bonnetain
authors.forename: P
authors.initials: P
authors.lastname: Rougier
authors.forename: C
authors.initials: C
authors.lastname: Mariette
authors.forename: O
authors.initials: O
authors.lastname: Bouché
authors.forename: J F
authors.initials: JF
authors.lastname: Bosset
authors.forename: T
authors.initials: T
authors.lastname: Aparicio
authors.forename: L
authors.initials: L
authors.lastname: Mineur
authors.forename: A
authors.initials: A
authors.lastname: Azzedine
authors.forename: P
authors.initials: P
authors.lastname: Hammel
authors.forename: J
authors.initials: J
authors.lastname: Butel
authors.forename: N
authors.initials: N
authors.lastname: Stremsdoerfer
authors.forename: P
authors.initials: P
authors.lastname: Maingon
authors.forename: L
authors.initials: L
authors.lastname: Bedenne
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001707:Biopsy, Needle; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D011336:Probability; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine