Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Not Applicable

Completed

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Radiation: Radiation Therapy

• Registration Number: NCT01186978
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2010-09-20
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Status Verified: 2020-05
• Results First Submitted: 2020-05-05
• Results First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Results First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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Exclusion Criteria

• Any contraindications to irradiation
• Primary CNS lymphoma
• HIV/AIDS

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Radiation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Local Control	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Local, Distant, or Local+Distant Failure	5 years	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.
Percentage of Participants With Progression-free Survival at 5 Years	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.
Percentage of Participants With Overall Survival	5 years	Overall survival will be defined as the number of participants who are alive

Trial Locations

Locations (3)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Duke Raleigh Hospital; 🇺🇸 Raleigh, North Carolina, United States

Durham Regional Hospital; 🇺🇸 Durham, North Carolina, United States