Spots Global Cancer Trial Database for Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
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Trial Identification
Brief Title: Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
Official Title: Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
Study ID: NCT00509184
Conditions
Interventions
Study Description
Brief Summary: Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.
Detailed Description: The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) 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. More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charité Campus Mitte, Berlin, , Germany
Charité Campus Benjamin-Franklin, Berlin, , Germany
Charité Campus Buch, Berlin, , Germany
University of Cologne, Cologne, , Germany
University of Dresden, Dresden, , Germany
University of Essen, Essen, , Germany
University of Göttingen, Göttingen, , Germany
University of Hannover, Hannover, , Germany
University of Heidelberg, Heidelberg, , Germany
University of Kiel, Kiel, , Germany
University of Mainz, Mainz, , Germany
University of Heidelberg (Campus Mannheim), Mannheim, , Germany
University of Marburg, Marburg, , Germany
LMU, Munich, , Germany
TU, Munich, , Germany
University of Münster, Münster, , Germany
University of Ulm, Ulm, , Germany
Contact Details
Name: Klaus Herfarth, MD
Affiliation: Heidelberg University
Role: PRINCIPAL_INVESTIGATOR
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