Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

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

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 Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27704
      • Durham Regional Hospital
    • Raleigh, North Carolina, United States, 27609
      • Duke Raleigh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of Participants With Overall Survival	Overall survival will be defined as the number of participants who are alive	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.	5 years

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Christopher Kelsey, MD, Duke University Medical Center, Radiation Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2010
• Primary Completion (ACTUAL): June 4, 2019
• Study Completion (ACTUAL): June 4, 2019

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (ESTIMATE): August 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: Pro00025164