NCT02964858Recruiting
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 · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- First submitted
- 12 Nov 2016
- Start date
- Nov 2016
- Primary completion date
- Mar 2026
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT02964858
What you commit to
- Study type: Interventional
- Planned participants: 840
- From Nov 2016 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of chemotherapy
- Prior history of radiotherapy.
Other illness
- HIV positive status.
- Relapse or progression of disease during chemotherapy.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Center Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.