Optimizing radiation doses for treating diffuse large B-cell lymphoma
Official title: Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.
Run by Tata Memorial Hospital · NCT02964858 · Data updated 2026-11-12
This study is testing if a lower radiation dose can effectively treat patients with diffuse large B-cell lymphoma while causing fewer side effects compared to the standard higher dose.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 840 (estimated) |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | chemotherapy, radiation, Rituximab, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | November 2016 |
| Main results expected | March 2026 |
| Study ends | November 2027 |
| Registry record updated | April 11, 2025 |
| Trial ID | NCT02964858 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-65 with a histological diagnosis of NHL-DLBCL who are eligible for radiation therapy after receiving R-CHOP chemotherapy.
✕Probably not a fit
Patients with HIV, those who have experienced disease progression during chemotherapy, or those with certain types of primary extranodal lymphomas may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness and safety of two different radiation dose regimens for patients with diffuse large B-cell lymphoma (NHL-DLBCL) following R-CHOP chemotherapy. One group will receive the standard dose of 45 Gray (Gy) in 25 fractions, while the other will receive a reduced dose of 36 Gy in 20 fractions. The goal is to determine if the lower dose can maintain treatment efficacy while reducing the risk of late side effects associated with higher radiation doses. Patients will be randomized into one of the two treatment arms after providing informed consent.
Why it matters
Potential benefit: If successful, this study could lead to a safer radiation treatment protocol that minimizes long-term side effects for patients with NHL-DLBCL.
How similar studies have gone: Previous studies have indicated the importance of optimizing radiation doses in lymphoma treatment, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tata Memorial Center
Mumbai, Maharashtra, India Recruiting
Study contacts
- Principal investigator: Jayant Sastri Goda, M.D — Professor,Tata Memorial Centre
- Study coordinator: Jayant Sastri Goda, M.D
- Email: godajayantsastri@gmail.com
- Phone: 919930004414
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.