Actively Recruiting
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.
Led by Tata Memorial Hospital · Updated on 2025-04-11
840
Participants Needed
1
Research Sites
573 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of Non-Hodgkin Lymphoma - Diffuse Large B-Cell Lymphoma (NHL-DLBCL).
- Eligible for radiation therapy after receiving R-CHOP chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3.
- Aged between 18 and 65 years.
- Disease stages I through IV.
- Received at least 4 cycles of R-CHOP chemotherapy.
- Have extranodal disease except those specified in exclusion criteria.
- Able to understand and willing to provide informed consent for the trial.
You will not qualify if you...
- HIV positive status.
- Disease relapse or progression during chemotherapy.
- Prior history of chemotherapy.
- Prior history of radiotherapy.
- Systemic lymphomas involving the central nervous system (CNS).
- Primary extranodal testicular lymphomas.
- Primary extranodal central nervous system (CNS) lymphomas.
- Primary extranodal stomach diffuse large B-cell lymphoma.
- Primary extranodal intestinal diffuse large B-cell lymphoma.
- Having more than 3 extranodal sites of disease.
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Trial Site Locations
Total: 1 location
1
Tata Memorial Center
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
J
Jayant Sastri Goda, M.D
CONTACT
S
Sangeeta kakoti, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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