To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))
Asan Medical Center
Seoul, South Korea
To compare 3-year event-free survival
definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy
Time frame: 3 years
To evaluate and compare OS between the two arms
Time frame: 3 years
To evaluate and compare the ORR and CR rate
Time frame: after completion of treatment
To evaluate and compare disease-free survival (DFS)
Time frame: 3 years
To evaluate treatment-failure pattern
Time frame: 3 years
Number of Participants with Adverse Events in each arm
Time frame: 3 years
To assess patient-reported outcomes (PROs) in both arms
Time frame: 3 years
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Time frame: 3 years
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