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Completed

NCT Number: NCT01186978

Reduced Radiation 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

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

Primary outcomes

  1. 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

  1. Percentage of Participants With Progression-free Survival at 5 Years

    Time frame: 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.

  2. Percentage of Participants With Overall Survival

    Time frame: 5 years

    Overall survival will be defined as the number of participants who are alive

  3. Number of Participants With Local, Distant, or Local+Distant Failure

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: DLBCL

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2010
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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