title: Chemoradiotherapy with concurrent gemcitabine and cisplatin with or without sequential chemotherapy with gemcitabine/cisplatin vs chemoradiotherapy with concurrent 5-fluorouracil in patients with locally advanced pancreatic cancer--a multi-centre randomised phase II study.
abstract: BACKGROUND
  No standard treatment for locally advanced pancreatic cancer (LAPC) is defined.
  
  
  METHODS
  Within a multi-centre, randomised phase II trial, 95 patients with LAPC were assigned to three different chemoradiotherapy (CRT) regimens: patients received conventionally fractionated radiotherapy of 50 Gy and were randomised to concurrent 5-fluorouracil (350 mg m(-2) per day on each day of radiotherapy, RT-5-FU arm), concurrent gemcitabine (300 mg m(-2)), and cisplatin (30 mg m(-2)) on days 1, 8, 22, and 29 (RT-GC arm), or the same concurrent treatment followed by sequential full-dose gemcitabine (1000 mg m(-2)) and cisplatin (50 mg m(-2)) every 2 weeks (RT-GC+GC arm). Primary end point was the overall survival (OS) rate after 9 months.
  
  
  RESULTS
  The 9-month OS rate was 58% in the RT-5-FU arm, 52% in the RT-GC arm, and 45% in the RT-GC+GC arm. Corresponding median survival times were 9.6, 9.3, and 7.3 months (P=0.61) respectively. The intent-to-treat response rate was 19, 22, and 13% respectively. Median progression-free survival was estimated with 4.0, 5.6, and 6.0 months (P=0.21). Grade 3/4 haematological toxicities were more frequent in the two GC-containing arms, no grade 3/4 febrile neutropaenia was observed.
  
  
  CONCLUSIONS
  None of the three CRT regimens tested met the investigators' definition for efficacy; the median OS was similar to those previously reported with gemcitabine alone in LAPC.
authors.affiliation: Department for Radiotherapy and Radiooncology, Klinik Bad Trissl, Oberaudorf, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Wilkowski
authors.forename: S
authors.initials: S
authors.lastname: Boeck
authors.forename: S
authors.initials: S
authors.lastname: Ostermaier
authors.forename: R
authors.initials: R
authors.lastname: Sauer
authors.forename: M
authors.initials: M
authors.lastname: Herbst
authors.forename: R
authors.initials: R
authors.lastname: Fietkau
authors.forename: M
authors.initials: M
authors.lastname: Flentje
authors.forename: S
authors.initials: S
authors.lastname: Miethe
authors.forename: H D
authors.initials: HD
authors.lastname: Boettcher
authors.forename: T
authors.initials: T
authors.lastname: Scholten
authors.forename: C J
authors.initials: CJ
authors.lastname: Bruns
authors.forename: H G
authors.initials: HG
authors.lastname: Rau
authors.forename: A
authors.initials: A
authors.lastname: Hinke
authors.forename: V
authors.initials: V
authors.lastname: Heinemann
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D015996:Survival Rate; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine