This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatment radiation therapy
Sponsor Duke University
Start date October 2010
End date May 2021
Trial size 62 participants
Trial identifier NCT01186978, Pro00025164


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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 therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week

Primary Outcomes

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

Secondary Outcomes

Progression-free survival
time frame: 5 year
Overall Survival
time frame: 5 years
To examine patterns of failure
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Principal investigator Christopher Kelsey, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Duke University.