Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Study Overview
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Brief Summary
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This study will evaluate whether a reduction in the 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 scan following rituximab-containing chemotherapy.

Official Title
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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy Negative post-chemotherapy (or interim) PET scan Absolute neutrophil count greater than 1500 and platelet count greater than 40,000 Negative pregnancy test in women of child-bearing potential For patients with HIV/AIDS, the following must be true: The patient is compliant on combination anti-retroviral therapy (CART) The patient has CD4 count ≥ 200 at time of diagnosis Exclusion Criteria: Any contraindications to irradiation Primary CNS lymphoma HIV/AIDS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. | Radiation: Radiation Therapy<br>* 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local Control | This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Progression-free Survival at 5 Years | Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first. | 5 years | 
| Percentage of Participants With Overall Survival | Overall survival will be defined as the number of participants who are alive | 5 years | 
| Number of Participants With Local, Distant, or Local+Distant Failure | To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only. | 5 years |