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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
This study is a prospective, single center, phase II clinical study involving 108 patients with primary and late stage Diffuse Large B-cell Lymphoma complicated by large masses and extranodal involvement. The study aims to evaluate the efficacy of radiotherapy targeting large masses and extranodal involvement in treatment-naïve advanced DLBCL patients with large mass lesions and/or extranodal involvement after they had initially been treated with standard immunochemotherapy and received complete remission as assessed by PET-CT. After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after their leaving the group, so as to obtain the relevant data and data of the 2-year Progression Free Survival, survival of the subjects and Treatment-related side effects.
Details
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | PHASE2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 108 |
| Start date | Mon May 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Advanced Diffuse Large B-Cell Lymphoma
- Extra-nodal Involvement, Large Mass
- Radiotherapy
Interventions
- 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy
- Radiotherapy beyond standard R-CHOP Chemotherapy