Abstract
BackgroundThe optimal treatment of early stage follicular Lymphoma is a matter of debate. Radiation therapy has frequently been applied with a curative approach beside watchful waiting. Involved field, extended field and total nodal radiation techniques are used in various protocols, but the optimal radiation field still has to be defined. Follicular lymphoma is characterized by stable expression of the CD20 antigen on the tumour cells surface. The anti CD20 antibody Rituximab (Mabthera®) has shown to be effective in systemic therapy of FL in primary treatment, relapse and maintenance therapy.Methods/designThe MIR (Mabthera® and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera®) in combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the study is progression free survival. Secondary endpoints are response rate to Rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life.DiscussionThe trial evaluates the efficacy of Rituximab to prevent out-filed recurrences in early stage nodal follicular lymphoma and the safety of the combination of Rituximab and involved field radiotherapy. It also might show additional risk factors for a later recurrence (e.g. remission state after Rituximab only).Trial RegistrationClinicalTrials (NCT): NCT00509184
Highlights
The optimal treatment of early stage follicular Lymphoma is a matter of debate
Median survival was above 12 years, in some of the international trials which categorized lymphomas according to the Working Formulation follicular lymphoma (FL) grade III and mantle cell lymphoma were part of the analysis
Forty-one percent of the patients had a relapse after 8 years in a prospective German observation trial with 117 patients with early stage FL who were treated with extended field (EF) or total nodal (TN)
Summary
The MIR trial is evaluating the effectiveness and the safety of the combination of an involved field radiation therapy with the systemic anti CD20 antibody Rituximab for early stage follicular lymphoma grade 1 or 2 in a multi center setting. It might show additional risk factors for a later recurrence (e.g. remission state after Rituximab only)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
