A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Undergoing Immunochemotherapy for PET-CT Assessment of Complete Remission

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

May 15, 2023

Primary Completion Date

May 15, 2026

Study Completion Date

May 15, 2026

Conditions
Advanced Diffuse Large B-Cell LymphomaExtra-nodal Involvement, Large MassRadiotherapy
Interventions
DRUG

6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy

All enrolled patients will first complete a total of 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy (Rituximab + Cyclophosphamide + Doxorubicin + Prednisolone) and conduct evaluation about treatment effects (i.e. efficacy evaluation) once every 2 cycles, and after their completion of the 6th cycle, they will receive maintenance treatment . After the end of 6th cycle of treatment or after their leaving the group, efficacy evaluation is conducted every three months to obtain relevant data regarding the 2-year Progression-Free Survival(PFS) and survival of the subjects.

RADIATION

Radiotherapy beyond standard R-CHOP Chemotherapy

Radiotherapy: after completion of the standard R-CHOP treatment, enrolled patients will be divided into radiotherapy group and non-radiotherapy group. In radiotherapy group, further consolidation radiotherapy targeting patients' pre-treatment large masses or extranodal affected areas will be given, with routine segmentation of 30-36Gy/15-18f.

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER

NCT05874778 - A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Undergoing Immunochemotherapy for PET-CT Assessment of Complete Remission | Biotech Hunter | Biotech Hunter