title: Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets.
abstract: OBJECTIVE
  The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer.
  
  
  METHODS
  A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group.
  
  
  RESULTS
  The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively.
  
  
  CONCLUSIONS
  Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. riccardo.casadei@aosp.bo.it.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Casadei
authors.affiliation: Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale (DIMES), Oncologia Medica-Biasco, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Mariacristina
authors.initials: M
authors.lastname: Di Marco
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Ricci
authors.affiliation: Anatomia Patologica-Grigioni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Santini
authors.affiliation: Medicina Interna-Morelli, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Serra
authors.affiliation: Radiologia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Calculli
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Marielda
authors.initials: M
authors.lastname: D'Ambra
authors.affiliation: Radioterapia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Guido
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Antonio Maria
authors.initials: AM
authors.lastname: Morselli-Labate
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Minni
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000368:Aged; D059186:Chemoradiotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
keywords: Chemoradiotherapy; Pancreatic cancer; Pancreatic resection