Clinical trial · Interventional
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
NCT01186978CI-TRIAL-00045356DLBCLcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity. Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Number of Participants With Local Control
- timeFrame
- 5 years
- description
- This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification * Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy * Negative post-chemotherapy (or interim) PET scan * Absolute neutrophil count greater than 1500 and platelet count greater than 40,000 * Negative pregnancy test in women of child-bearing potential For patients with HIV/AIDS, the following must be true: * The patient is compliant on combination anti-retroviral therapy (CART) * The patient has CD4 count ≥ 200 at time of diagnosis Exclusion Criteria: * Any contraindications to irradiation * Primary CNS lymphoma * HIV/AIDS
References
Publications (0)
Data not yet available
No reference posted for this study.