This phase II trial studies how well dose-reduced consolidation radiation therapy works in treating patients with stage I-IV diffuse large B-cell lymphoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving a lower dose of radiation therapy after chemotherapy may decrease both acute side effects and long-term risks of the treatment in patients with diffuse large B-cell lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03681535.
PRIMARY OBJECTIVE:
I. To determine if high rates of local control can be maintained after a reduction in the radiation therapy (RT) dose (from 30 Gy to 20 Gy) after 3 to 6 cycles of chemo-immunotherapy.
SECONDARY OBJECTIVES:
I. To determine disease-free survival and overall survival after chemotherapy and low-dose (20 Gy) consolidation radiation therapy.
II. To identify patterns of failure after combined modality therapy using lower doses of consolidation RT.
OUTLINE:
Within 4 weeks of completing chemo-immunotherapy, patients undergo dose-reduced radiation therapy 5 days a week for a total of 10-13 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for up to 10 years.
Lead OrganizationDuke University Medical Center
Principal InvestigatorChristopher Kelsey
