Clinical trial · Interventional
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority 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 purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions. The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.
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 |
|---|---|---|---|
| NonHodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental Arm | Radiation | — | UNRESOLVED |
| Standard Arm | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- 45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
- interventionNames
- Radiation: Standard Arm
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
- interventionNames
- Radiation: Experimental Arm
Primary outcomes (1)
- measure
- Event Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histological Diagnosis of NHL- DLBCL. * Eligible for RT after R-CHOP. * ECOG 0-3. * 18 - 65 years. * Stage I-IV. * Patients should receive at least 4 cycles of R-CHOP chemotherapy. * Patients with all extranodal disease except the ones mentioned in the exclusion criteria. * Able to understand and willing to provide informed consent for participation in the trial. Exclusion Criteria: * HIV positive status. * Relapse or progression of disease during chemotherapy. * Prior history of chemotherapy * Prior history of radiotherapy. * Systemic lymphomas with CNS involvement. * Primary extranodal Testicular Lymphomas. * Primary extranodal central nervous system (CNS) Lymphomas. * Primary extranodal Stomach DLBCL * Primary extranodal Intestinal DLBCL * Patients \>3 extranodal sites
References
Publications (0)
Data not yet available