Phase III study of watchful waiting vs. rituximab as first-line treatment in advanced stage follicular lymphoma with low tumour burden (JCOG1411, FLORA study)

This study aimed to confirm the superiority of early administration of first-line rituximab in terms of event-free survival to watchful waiting for stages III and IV follicular lymphoma with low tumour burden. A total of 290 patients will be accrued from 50 Japanese institutions within 5 years. The primary endpoint is event-free survival defined as the period from registration to diagnosis of high tumour burden, therapy using cytotoxic chemotherapy and/or radiotherapy, or death. The secondary endpoints are overall survival, progression-free survival, cytotoxic chemotherapy/radiotherapy-free survival, histological transformation-free survival, response rate, adverse events and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000025187 (http://www.umin.ac.jp/ctr/index.htm).
Source: Japanese Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research