Optimizing radiation doses for treating diffuse large B-cell lymphoma
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | chemotherapy, radiation, Rituximab, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT02964858 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated the importance of optimizing radiation doses in lymphoma treatment, suggesting that this approach may yield beneficial results.
Eligibility criteria
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 this trial is running
Mumbai, Maharashtra
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.