Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diffuse Large B-cell Lymphoma
- Sponsor
- Duke University
- Enrollment
- 63
- Locations
- 3
- Primary Endpoint
- Number of Participants With Local Control
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of Participants With Local Control
Time Frame: 5 years
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 Outcomes
- Percentage of Participants With Progression-free Survival at 5 Years(5 years)
- Percentage of Participants With Overall Survival(5 years)
- Number of Participants With Local, Distant, or Local+Distant Failure(5 years)