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.
RCT Entities:
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.
Authors: Ainhoa Madariaga; Jenny Lau; Arunangshu Ghoshal; Tomasz Dzierżanowski; Philip Larkin; Jacek Sobocki; Andrew Dickman; Kate Furness; Rouhi Fazelzad; Gregory B Crawford; Stephanie Lheureux Journal: Support Care Cancer Date: 2022-03-10 Impact factor: 3.359