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

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ClinicalTrials.gov Identifier: NCT03681535
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:

This phase II study will evaluate whether a reduction in 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-CT scan following rituximab - containing chemotherapy.


Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Radiation: Radiation Therapy Not Applicable

Detailed Description:

Chemotherapy followed by consolidation radiation therapy (RT) is a recognized treatment paradigm for DLBCL. This was initially established based on the results of 2 randomized trials conducted in the 1980s-1990s. In these studies patients were treated with 30Gy after chemotherapy (ECOG study) or 40-55Gy (SWOG study). A British National Lymphoma Investigation study showed no difference in freedom from local progression, progression-free survival or overall survival in between patients receiving 30Gy and 40-45Gy. Additionally systemic therapy for DLBCL has significantly improved since these initial studies, with the addition of rituximab to standard chemotherapy.

In a phase II study at Duke University patients with DLBCL NOS or primary mediastinal B-cell lymphoma were treated to 19.5-20Gy after achieving complete response to 4-6 cycles of chemotherapy containing rituximab. With a median follow-up of 43 months, there was only 1 local recurrence. The 5-year local control rate was 98%. Progression-free and overall survival at 5 years was 81% and 88%. Therefore, there is emerging evidence of long term favorable outcomes in localized DLBCL, while decreasing the risk of late effects by reducing the dose and volume of RT.

All participants will receive 20Gy instead of 30-36Gy after completion of at least 3 cycles of rituximab with combination chemotherapy. Participants must have a negative post chemotherapy PET-CT to participate in this study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Single arm interventional study
RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments).
Radiation: Radiation Therapy
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 complete response and have a negative post-chemotherapy PET scan following 3 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.




Primary Outcome Measures :
  1. Local control rate [ Time Frame: 5 years ]
    Local control rate of 95% measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
    Disease-free survival (DFS) will be defined as the time from on-study to first disease progression or death due to any cause, whichever comes first.

  2. Overall Survival [ Time Frame: 5 years ]
    Overall survival will be defines as the time from on-study to death due to any cause.

  3. Patterns of failure [ Time Frame: 5 years ]
    To examine patterns of failure we, we will tabulate the various ways that patients failed, up until the time of analysis. For example, these ways will include local only, local + distant, and distant only.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of stage I-IV diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS) and all entities within this category as defined in the WHO classification. Double hit, triple hit, double expressor and triple expressor phenotypes are eligible.
  • Completion of at least 3 cycles of rituximab-containing, anthracycline-based combination chemotherapy
  • Negative post-chemotherapy PET-CT scan
  • Absolute neutrophil count greater than 1000 and platelet count greater than 40,000
  • Negative pregnancy test in women of child-bearing potential
  • Signed study specific informed consent

Exclusion Criteria:

  • Primary central nervous system lymphoma, primary cutaneous DLBCL, leg type. T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, or other distinct non-Hodgkin lymphomas arising from large B-cells included in the WHO classification
  • Any absolute contraindications to irradiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681535


Contacts
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Contact: Josephine Gaston, BSN MPH 919-668-3726 josephine.gaston@duke.edu
Contact: Joan Cahill, BNS OCN CCRP 919 6683726 joan.cahill@dm.duke.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    Worrall.Hannah@mayo.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Christopher Kelsey, MD         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03681535     History of Changes
Other Study ID Numbers: Pro00100510
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
DLBCL
Reduce radiation dose

Additional relevant MeSH terms:
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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