Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

NCT ID: NCT01186978

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-20
• Study Completion Date: 2019-06-04

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Radiation Therapy

Intervention Type: RADIATION

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

Interventions

Radiation Therapy

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

Intervention Type: RADIATION

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
• HIV/AIDS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Kelsey, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Radiation Oncology

Locations

Durham Regional Hospital

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Duke Raleigh Hospital

Raleigh, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00025164

Identifier Type: -

Identifier Source: org_study_id