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

This study is currently recruiting participants.

Verified April 2013 by Duke University

Sponsor:

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT01186978

First received: August 19, 2010

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2010

Last Updated Date

April 15, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01186978 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diffuse Large B-cell Lymphoma

Intervention ^ICMJE

Radiation: Radiation Therapy

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2016

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01186978

Other Study ID Numbers ^ICMJE

Pro00025164

Has Data Monitoring Committee

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christopher Kelsey, MD

Duke University Medical Center, Radiation Oncology

Information Provided By

Duke University

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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