Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Diffuse Large B-cell Lymphoma Clinical Trial

— DLBCL  

Official title:

Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186978
• Other study ID #: Pro00025164
• Status: Completed
• Phase: N/A
• Start date: September 20, 2010
• Est. completion date: June 4, 2019

Study information

• Verified date: May 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Radiation:
• Radiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Regional Hospital	Durham	North Carolina
United States	Duke Raleigh Hospital	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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.	5 years
Secondary	Percentage of Participants With Overall Survival	Overall survival will be defined as the number of participants who are alive	5 years
Secondary	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.	5 years