Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

This study is currently recruiting participants.
Verified September 2011 by Duke University

First Received on August 19, 2010.  
Last Updated on September 29, 2011  
History of Changes
This Clinical Trial Sponsored By: Duke University
Collaborator: department of radiation oncology
Information provided by (Responsible Party): Duke University
ClinicalTrials.gov Identifier: NCT01186978
 

Purpose for Clinical Trial

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.

Condition Study Intervention
Diffuse Large B-cell Lymphoma Radiation: Radiation Therapy

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures For Clinical Trial:

  • Actuarial Freedom from Local Failure [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: October 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Radiation: Radiation Therapy

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Any contraindications to irradiation
  • Primary CNS lymphoma
  • HIV/AIDS
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186978

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Kelsey, MD     919-668-5213     christopher.kelsey@duke.edu    
Principal Investigator: Christopher Kelsey, MD            
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Bridget Koontz, MD     919-470-8600        
Principal Investigator: Bridget Koontz, MD            
Duke Raleigh Hospital Enrolling by invitation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
department of radiation oncology
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186978    
History of Changes
Other Study ID Numbers: Pro00025164
Study First Received: August 19, 2010
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 21, 2012

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