title: Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer.
abstract: OBJECTIVE
  To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer.
  
  
  METHODS
  The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62 years, median tumour size 40 mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20×2.5 Gy radiotherapy combined with UFT 300 mg/m(2) per day, leucovorin (folinic acid) 30 mg and celecoxib 80 0mg for 28 days concomitant with radiotherapy. Four patients were lost to follow-up.
  
  
  RESULTS
  Full treatment compliance was achieved in 55% of patients, 80% received at least 3 weeks of treatment. No partial or complete response was observed. Median survival was 10.6 months and median time to progression 6.9 months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths.
  
  
  CONCLUSIONS
  Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.
authors.affiliation: Department of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: Marjolein J M
authors.initials: MJ
authors.lastname: Morak
authors.forename: Dick J
authors.initials: DJ
authors.lastname: Richel
authors.forename: Casper H J
authors.initials: CH
authors.lastname: van Eijck
authors.forename: Joost J M E
authors.initials: JJ
authors.lastname: Nuyttens
authors.forename: Ate
authors.initials: A
authors.lastname: van der Gaast
authors.forename: Walter L
authors.initials: WL
authors.lastname: Vervenne
authors.forename: Esther E
authors.initials: EE
authors.lastname: Padmos
authors.forename: Eva E
authors.initials: EE
authors.lastname: Schaake
authors.forename: Olivier R C
authors.initials: OR
authors.lastname: Busch
authors.forename: Geertjan
authors.initials: G
authors.lastname: van Tienhoven
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068579:Celecoxib; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014498:Uracil / Q000008:administration & dosage
chemical_list: D011720:Pyrazoles; D013449:Sulfonamides; D005641:Tegafur; D014498:Uracil; D000068579:Celecoxib; D002955:Leucovorin