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

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ClinicalTrials.gov Identifier: NCT01186978
Recruitment Status : Active, not recruiting
First Posted : August 23, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

August 19, 2010
August 23, 2010
January 23, 2018
October 2010
May 2021   (Final data collection date for primary outcome measure)
To determine if high rates of local control can be maintained after a reduction in the RT dose and volume after 4 to 6 cycles of rituximab containing chemotherapy. [ Time Frame: 5 year ]
This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the observed 5-year LC rate, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
Actuarial Freedom from Local Failure [ Time Frame: 5 year ]
Complete list of historical versions of study NCT01186978 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 5 year ]
    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.
  • Overall Survival [ Time Frame: 5 years ]
    Overall survival will be defined as the time from on-study to death due to any case.
  • To examine patterns of 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.
Progression-free survival [ Time Frame: 5 years ]
Not Provided
Not Provided
 
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
Dose-Reduced Consolidation Radiation Therapy 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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
Radiation: Radiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
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.
Intervention: Radiation: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
Same as current
May 2022
May 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01186978
Pro00025164
No
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Radiation Oncology
Duke University
January 2018

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