title: Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.
abstract: BACKGROUND
  Malignant bowel obstruction (MBO) is common in patients with advanced cancer.
  
  
  OBJECTIVE
  To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO.
  
  
  METHODS
  Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo.
  
  
  RESULTS
  Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment).
  
  
  CONCLUSIONS
  It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.
authors.affiliation: 1Department of Surgery, The University of Auckland, New Zealand.
authors.forename: Cindy
authors.initials: C
authors.lastname: Lee
authors.forename: Ryash
authors.initials: R
authors.lastname: Vather
authors.forename: Anne
authors.initials: A
authors.lastname: O'Callaghan
authors.forename: Jackie
authors.initials: J
authors.lastname: Robinson
authors.forename: Briar
authors.initials: B
authors.lastname: McLeod
authors.forename: Michael
authors.initials: M
authors.lastname: Findlay
authors.forename: Ian
authors.initials: I
authors.lastname: Bissett
mesh_terms: D003974:Diatrizoate Meglumine; D005240:Feasibility Studies; D006801:Humans; D007415:Intestinal Obstruction / Q000628:therapy; D010166:Palliative Care
chemical_list: D003974:Diatrizoate Meglumine
keywords: feasibility study; gastrografin; malignant bowel obstruction; palliative care; symptom management.