Back to resultsReduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Primary Purpose
Diffuse Large B-cell Lymphoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- Durham Regional Hospital
- Duke University Medical Center
- Duke Raleigh Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percentage of Participants With Overall Survival
Overall survival will be defined as the number of participants who are alive
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01186978
Brief Title
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
Acronym
DLBCL
Official Title
Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2010 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Primary Outcome Measure Information:
Title
Number of Participants With Local Control
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Progression-free Survival at 5 Years
Description
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.
Time Frame
5 years
Title
Percentage of Participants With Overall Survival
Description
Overall survival will be defined as the number of participants who are alive
Time Frame
5 years
Title
Number of Participants With Local, Distant, or Local+Distant Failure
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kelsey, MD
Organizational Affiliation
Duke University Medical Center, Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
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