Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
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|ClinicalTrials.gov Identifier: NCT01186978|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2010
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Radiation: Radiation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
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
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
- To determine if high rates of local control can be maintained after a reduction in the RT dose and volume after 4 to 6 cycles of rituximab containing chemotherapy. [ Time Frame: 5 year ]This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the observed 5-year LC rate, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
- Progression-free survival [ Time Frame: 5 year ]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.
- Overall Survival [ Time Frame: 5 years ]Overall survival will be defined as the time from on-study to death due to any case.
- To examine patterns of failure [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186978
|United States, North Carolina|
|Durham Regional Hospital|
|Durham, North Carolina, United States, 27704|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Duke Raleigh Hospital|
|Raleigh, North Carolina, United States, 27609|
|Principal Investigator:||Christopher Kelsey, MD||Duke University Medical Center, Radiation Oncology|