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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037528
Receipt No. R000042274
Scientific Title Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/29

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Basic information
Public title Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Acronym Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scientific Title Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scientific Title:Acronym Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Region
Japan

Condition
Condition diffuse large B cell lymphoma
Classification by specialty
Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This phase II study will evaluate whether a reduction in the dose of consolidation RT in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, 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. International Lymphoma Radiation Oncology Group proposed a phase II clinical trial to test the dose reduction in this setting. The trial is conducted by Dr. Christopher Kelsey, Duke University. We designed this phase II independent institutional trial under control by the ILROG. We are planning to provide our data to the ILROG trial.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes To determine if high rates of local control can be maintained after a reduction in the RT dose (from 30 Gy to 20 Gy) after 3 to 6 cycles of chemo-immunotherapy.
Key secondary outcomes To determine disease-free survival and overall survival after chemotherapy and low-dose (20 Gy) consolidation radiation therapy.
To identify patterns of failure after combined modality therapy using lower doses of consolidation RT

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 RT will be administered daily, 5 days/week. Patients will be treated with 1.5-2 Gy fractions to a total dose of 19.5-20 Gy. Daily image guidance recommended but not mandated.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 20 years of age or older
Histologic documentation of stage 1-4 diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), as defined by the 2016 WHO classification. This would include all entities within this category including germinal center B-cell and non-germinal center B cell type. Further, double hit, triple hit, double expressor, and triple expressor phenotypes are eligible.
Completion of at least 3 cycles of a rituximab-containing, anthracycline-based combination chemotherapy regimen (R-CHOP preferred but not mandated).
Negative post chemotherapy PET-Scan
ANC more than 1000 and platelet count more than 40,000
Negative pregnancy test in women of child-bearing potential within 24 hours of initiating RT.
Signed study-specific informed consent
Key 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.

Target sample size 16

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Sasai
Organization Juntendo University
Faculty of Medicine
Division name Department of Radiation Oncology
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Email ksasai@juntendo.ac.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Sasai
Organization Juntendo University Hospital
Division name Department of Radiology
Zip code 113-8421
Address 3-1-3 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ksasai@juntendo.ac.jp

Sponsor
Institute Department of Radiology, Juntendo University Hospital, Juntendo University
Institute
Department

Funding Source
Organization Department of Radiation Oncology, Faculty of Medicine, Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital
Address 3-1-3 Hongo, Bunkyo, Tokyo, Japan
Tel 03-3813-3111
Email kenkyu5858@juntendo.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 06 Month 19 Day
Date of IRB
2019 Year 07 Month 26 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2034 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 29 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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