Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients

The objective of this study is to evaluate the preventive effects of landiolol hydrochloride, which is an ultra-short-acting beta-1-selective blocker that has been developed in Japan, on reducing recurrence of cancer after curative surgery for patients with lung cancer.MethodsThe present study is a phase III, multicenter, randomized trial with two parallel groups of patients with lung cancer, comparing surgery alone and surgery with landiolol administration for three  days during the perioperative period. A total of 400 patients will be enrolled from 12 Japanese institutions. The primary endpoint is two-year relapse-free survival and overall survival after curative surgery for lung cancer. The secondary endpoints are additional treatment after recurrence of ca ncer, safety events, and the incidence of postoperative complications.DiscussionThe principal question addressed in this trial is whether landiolol can reduce recurrence of cancer after curative surgery for lung cancer.Trial registrationJapan Registry of Clinical Trials,jRCT2011180004. Registered 17 January 2019.
Source: Trials - Category: Research Source Type: clinical trials