UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037528 |
|---|---|
| Receipt number | 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 | 2024/01/31 13:01:41 |
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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 | Naoto |
| Middle name | |
| Last name | Shikama |
Organization
Juntendo University
Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
n-shikama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Shikama |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
1138421
Address
3-1-3 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
n-shikama@juntendo.ac.jp
Sponsor or person
Institute
Department of Radiology, Juntendo University Hospital, Juntendo University
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042274
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