Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.
DOBL
1 other identifier
interventional
840
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedApril 11, 2025
April 1, 2025
9.3 years
November 12, 2016
April 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival
From the time of randomization till relapse or progression or death due to any cause or death due to disease. Assessment by physiological parameter
2 years
Secondary Outcomes (6)
Local Control Rate
2 years
Overall Survival
2 years
Overall response rate
3 months
Late toxicity
2 years
Acute toxicity
During radiation to 6 weeks from the end of radiation
- +1 more secondary outcomes
Study Arms (2)
Standard Arm
ACTIVE COMPARATOR45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
Experimental Arm
EXPERIMENTAL36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
Interventions
Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.
Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.
Eligibility Criteria
You may qualify if:
- Histological Diagnosis of NHL- DLBCL.
- Eligible for RT after R-CHOP.
- ECOG 0-3.
- years.
- Stage I-IV.
- Patients should receive at least 4 cycles of R-CHOP chemotherapy.
You may not qualify if:
- Able to understand and willing to provide informed consent for participation in the trial.
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Center
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayant Sastri Goda, M.D
Professor,Tata Memorial Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 12, 2016
First Posted
November 16, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share