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Published on: March 25, 2022
Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel
Cindy Lee1, Ryash Vather, Anne O'Callaghan
11Department of Surgery, The University of Auckland, New Zealand.
Background:
Malignant bowel obstruction (MBO) is common in patients with advanced cancer.
Aim:
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.
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