An open-label, randomized phase III trial comparing local radiotherapy alone or combined with Obinutuzumab in early stage Follicular Lymphoma: the GAZEBO Trial from the Fondazione Italiana Linfomi

Limited-stage follicular lymphoma (FL) is traditionally treated with involved-field radiotherapy (IFRT); however, alternative approaches are currently being adopted, ranging from simple observation (the “watch and wait” approach) to combination treatments. 
Doses of 24 Gy delivered to the involved lymph nodes are able to eradicate the disease in only 40–50% of patients. Anti-CD20 monoclonal antibodies, which are widely used in advanced-stage FL, could be effective in reducing the risk of relapse, but there is currently no scientific evidence supporting their role; current guidelines do not include immunotherapy among the treatment strategies for localized FL. 
A phase II study recently conducted in early-stage FL by the German group (MIR study) introduced a treatment modality combining 24 Gy radiotherapy with Rituximab, yielding good results in terms of progression-free survival (PFS); however, this study lacked a control group and therefore the results have not influenced clinical practice. 
The aim of the present study is to evaluate the role of radioimmunotherapy as a first-line treatment for limited-stage FL compared to radiotherapy alone through a randomized design.