Clinical trial · Interventional
The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma
The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy. Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for patients with stage III-IV DLBCL. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation involved-field radiotherapy (IFRT) | Radiation | — | UNRESOLVED |
| Consolidation involved-site radiotherapy (ISRT) | Radiation | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ISRT group
- description
- Six cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals) . Consolidation involved-site radiotherapy (ISRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy.
- interventionNames
- Radiation: Consolidation involved-site radiotherapy (ISRT)
- Drug: cyclophosphamide
- Drug: doxorubicin
- Drug: vincristine
- Drug: prednisone
- type
- ACTIVE_COMPARATOR
- label
- IFRT group
- description
- Six cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals). Consolidation involved-field radiotherapy (IFRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Both male and female aged range from 18 years to 65 years. * Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1. * All patients had histologically confirmed Diffuse large B-cell lymphoma. * Advanced-stage DLBCL patients at newly diagnosed or recurrent without RT in initial management. * Adequate organ function. * Negative pregnancy test. * Signed informed consent document on file. Exclusion Criteria: * Woman who were pregnant or lactating. * With severe local infection or general infective disease. * Primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung. * With other second primary malignancy except cutaneum carcinoma. * Being or planning to participate in other study. * Any patient who in the opinion of the investigator should not participate in the study. Withdrawal Criteria: * Patient are free to withdrawal completely from the study at any time upon request. * Patient in the study may be stopped with the patient agreement at any time at the discretion of investigator. * In-field progression on irradiation ongoing. * Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
References
Publications (0)
Data not yet available