Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

NCT01186978 | Completed Results

• 1 other identifier: Pro00025164
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Single arm

OTHER

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

Interventions

Radiation Therapy RADIATION

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

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any contraindications to irradiation
• Primary CNS lymphoma
• HIV/AIDS

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Assistant Research Practice Manager (ARPM) for Clinical Trials
• Organization: Duke University Health System

Jennifer.Mewshaw@duke.edu

919-668-5211

Study Officials

• Christopher Kelsey, MD

  Duke University Medical Center, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: September 20, 2010
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Locations

US (3)