title: Radiation plus docetaxel and cisplatin in locally advanced pancreatic carcinoma: a non-comparative randomized phase II trial.
abstract: BACKGROUND
  We performed a randomized, non-comparative phase II study evaluating docetaxel in combination with either daily continuous (protracted IV) 5-fluorouracil or cisplatin administered weekly, concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma. Results of the docetaxel plus cisplatin regimen are reported.
  
  
  METHODS
  Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20mg/m(2) and cisplatin 20mg/m(2)/week, plus concurrent radiotherapy for 6 weeks. The radiation dose to the primary tumour was 54Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate.
  
  
  RESULTS
  51 patients from 7 centres were included in the docetaxel-cisplatin treatment group. Six-month non-progression rate was 39% (95% confidence interval: 26-53). Median overall survival was 9.6 months (95% confidence interval: 2.4-60.7); 6 complete and 8 partial responses were obtained. Six patients survived more than 2 years after their inclusion in the trial. Grade ≥3 toxicity was reported in 63% of patients; no treatment-related death occurred. Severe toxicities were mainly anorexia (22%), vomiting (20%) and fatigue (24%).
  
  
  CONCLUSIONS
  Despite inadequate efficacy according to the main end point, this regimen gave a satisfactory rate of objective response (27%) with tolerable toxicity.
authors.affiliation: Gustave Roussy, Villejuif, France; Université Paris Sud, Le Kremlin Bicetre, France. Electronic address: michel.ducreux@gustaveroussy.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
authors.affiliation: Institut Paoli Calmettes, Marseille, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Giovannini
authors.affiliation: Gustave Roussy, Villejuif, France.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Baey
authors.affiliation: Institut du Cancer Montpellier - Val d'Aurelle, Montpellier, France.
authors.forename: Carmen
authors.initials: C
authors.lastname: Llacer
authors.affiliation: Institut de Cancérologie de l'Ouest - René Gauducheau, Nantes, France.
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.affiliation: Centre Oscar Lambret, Lille, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
authors.affiliation: Institut de Cancérologie de Lorraine - Alexis Vautrin, Nancy, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Peiffert
authors.affiliation: Hôpital Lyon Sud, Lyon, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Mornex
authors.affiliation: Gustave Roussy, Villejuif, France.
authors.forename: Moncef
authors.initials: M
authors.lastname: Abbas
authors.affiliation: Gustave Roussy, Villejuif, France.
authors.forename: Valèrie
authors.initials: V
authors.lastname: Boige
authors.affiliation: Gustave Roussy, Villejuif, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pignon
authors.affiliation: Institut de Cancérologie de Lorraine - Alexis Vautrin, Nancy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
authors.affiliation: Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Cellier
authors.affiliation: Unicancer, Paris, France.
authors.forename: Beata
authors.initials: B
authors.lastname: Juzyna
authors.affiliation: Institut Paoli Calmettes, Marseille, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Viret
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Cisplatin; Docetaxel; Pancreatic carcinoma; Radio-chemotherapy