The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems to show a high CR rate based on the 50% of the patients. This is in contrast to the FORT trial, which showed an inferiority of the 4 Gy dose compared to the standard dose (24 Gy) in terms of response and progression free survival. The goal of the FORTplus trial is to prove (1) the non-inferiority of LDRT (4Gy) in a combined approach with an anti-CD20-antibody. In case of non-inferiority, a possible (2) superiority of the Obinutuzumab + LDRT should be tested against Rituximab + standard dose using the same test set. The radiation dose can significantly be reduced to 16% of the standard dose if (1) is confirmed. Knowing the data of the FORT trial, this would have a significant influence on the treatment of the disease worldwide even if the difference in the CR rate at week 18 is not as high as currently in the historical comparison expected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
12 x 2 Gy involved site radiotherapy plus Rituximab
2 x2 Gy involved site radiotherapy plus Obinutuzumab
Rituximab with 12 x 2 Gy involved site radiotherapy
Obinutuzumab with 2 x2 Gy involved site radiotherapy
Vivantes Klinikum Berlin
Berlin, Germany
RECRUITINGUniversity of Essen
Essen, Germany
RECRUITINGUniversity of Göttingen
Göttingen, Germany
RECRUITINGUniversity Hospital Heidelberg
Heidelberg, Germany
RECRUITINGStrahlentherapie KH Maria Hilf
Mönchengladbach, Germany
RECRUITINGLMU München
Munich, Germany
RECRUITINGTechnische Universität München
Munich, Germany
RECRUITINGKrankenhaus Barmherzige Brüder
Regensburg, Germany
RECRUITINGUniversity of Rostock
Rostock, Germany
RECRUITINGKatharinen Hospital Stuttgart
Stuttgart, Germany
RECRUITING...and 2 more locations
Morphologic complete response
Rate of morphologic complete response based on CT scan in patients with initially remaining lymphoma
Time frame: Week 18
Metabolic complete response
Rate of metabolic complete response based on FDG PET in patients with initially remaining lymphoma
Time frame: week 18
Morphologic response
Morphologic CR in patients with initially remaining lymphoma
Time frame: Month 6
PFS
Progression-free survival (PFS) of each treatment arm
Time frame: 2 years
Frequency and extent of Toxicity
Toxicity (NCI-CTC criteria, version 5) of all patients
Time frame: until month 30
Overall survival
Overall survival (OS) of each treatment arm
Time frame: 2 years
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