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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Durham Regional Hospital
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
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.
Time frame: 5 years
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.
Time frame: 5 years
Percentage of Participants With Overall Survival
Overall survival will be defined as the number of participants who are alive
Time frame: 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.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.