Description:
This phase II study will evaluate whether a reduction in radiation dose and field size will
maintain a high rate of local control while minimizing the risk of acute and late toxicity .
Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy
while maintaining high rates of local control in patients who had a negative PET-CT scan
following rituximab - containing chemotherapy.
Title
- Brief Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
- Official Title: Phase II Study of Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
Pro00100510
- NCT ID:
NCT03681535
Conditions
- Diffuse Large B Cell Lymphoma
Purpose
This phase II study will evaluate whether a reduction in radiation dose and field size will
maintain a high rate of local control while minimizing the risk of acute and late toxicity .
Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy
while maintaining high rates of local control in patients who had a negative PET-CT scan
following rituximab - containing chemotherapy.
Detailed Description
Chemotherapy followed by consolidation radiation therapy (RT) is a recognized treatment
paradigm for DLBCL. This was initially established based on the results of 2 randomized
trials conducted in the 1980s-1990s. In these studies patients were treated with 30Gy after
chemotherapy (ECOG study) or 40-55Gy (SWOG study). A British National Lymphoma Investigation
study showed no difference in freedom from local progression, progression-free survival or
overall survival in between patients receiving 30Gy and 40-45Gy. Additionally systemic
therapy for DLBCL has significantly improved since these initial studies, with the addition
of rituximab to standard chemotherapy.
In a phase II study at Duke University patients with DLBCL NOS or primary mediastinal B-cell
lymphoma were treated to 19.5-20Gy after achieving complete response to 4-6 cycles of
chemotherapy containing rituximab. With a median follow-up of 43 months, there was only 1
local recurrence. The 5-year local control rate was 98%. Progression-free and overall
survival at 5 years was 81% and 88%. Therefore, there is emerging evidence of long term
favorable outcomes in localized DLBCL, while decreasing the risk of late effects by reducing
the dose and volume of RT.
All participants will receive 20Gy instead of 30-36Gy after completion of at least 3 cycles
of rituximab with combination chemotherapy. Participants must have a negative post
chemotherapy PET-CT to participate in this study.
Trial Arms
Name | Type | Description | Interventions |
---|
Single arm interventional study | Experimental | RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments). | |
Eligibility Criteria
Inclusion Criteria:
- Histologic documentation of stage I-IV diffuse large B-cell lymphoma, not otherwise
specified (DLBCL NOS), as defined by the 2016 WHO classification. This would include
all entities within this category including germinal center B-cell and non-germinal
center B-cell subtypes and those with a double expressor phenotype. Also eligible are
stage I-IV high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and
high-grade B-cell lymphoma, NOS
- Completion of at least 3 cycles of rituximab-containing, anthracycline-based
combination chemotherapy
- Negative post-chemotherapy PET-CT scan or negative interim PET-CT scan performed
within 2 weeks of the final cycle of chemoimmunotherapy. This is defined as a score of
1-3 on the PET Five Point (Deauville) Scale using the Modified Lugano Response
Criteria for Non-Hodgkin's Lymphoma
- Absolute neutrophil count greater than 1000 and platelet count greater than 40,000
- Negative pregnancy test in women of child-bearing potential
- Signed study specific informed consent
Exclusion Criteria:
- Primary central nervous system lymphoma, primary cutaneous DLBCL, leg type.
T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large
B-cell lymphoma, or other distinct non-Hodgkin lymphomas arising from large B-cells
included in the WHO classification
- Any absolute contraindications to irradiation
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Local control rate |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Local control rate of 95% measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines |
Secondary Outcome Measures
Measure: | Disease-free survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Disease-free survival (DFS) will be defined as the time from on-study to first disease progression or death due to any cause, whichever comes first. |
Measure: | Overall Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Overall survival will be defines as the time from on-study to death due to any cause. |
Measure: | Patterns of failure |
Time Frame: | 5 years |
Safety Issue: | |
Description: | To examine patterns of failure we, we will tabulate the various ways that patients failed, up until the time of analysis. For example, these ways will include local only, local + distant, and distant only. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Duke University |
Trial Keywords
- DLBCL
- Reduce radiation dose
Last Updated
July 26, 2021