NCT02964858 Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.
| NCT ID | NCT02964858 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Hospital |
| Condition | NonHodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 840 participants |
| Start Date | 2016-11 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 840 participants in total. It began in 2016-11 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jayant Sastri Goda, M.D
PRINCIPAL INVESTIGATOR
Professor,Tata Memorial Centre
Frequently Asked Questions
Who can join the NCT02964858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying NonHodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02964858 currently recruiting?
Yes, NCT02964858 is actively recruiting participants. Contact the research team at godajayantsastri@gmail.com for enrollment information.
Where is the NCT02964858 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT02964858 clinical trial?
NCT02964858 is sponsored by Tata Memorial Hospital. The principal investigator is Jayant Sastri Goda, M.D at Professor,Tata Memorial Centre. The trial plans to enroll 840 participants.