UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026684 |
|---|---|
| Receipt number | R000030023 |
| Scientific Title | A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma. |
| Date of disclosure of the study information | 2017/03/25 |
| Last modified on | 2022/04/24 16:32:01 |
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Basic information
Public title
A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.
Acronym
NHOH-CUA-DLBCL
Scientific Title
A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.
Scientific Title:Acronym
NHOH-CUA-DLBCL
Region
| Japan |
Condition
Condition
Untreated limited-stage DLBCL
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the cost-effectiveness of a long course of R-CHOP therapy and radiation therapy after a short course of R-CHOP therapy respectively in Japan in treatment naive adults with untreated limited-stage DLBCL. Also to clarify the actual condition of treatment outcome, QOL and treatment-related cost, and to search for background factors of patients related to doctor's treatment selection in the limited-stage DLBCL.
Basic objectives2
Others
Basic objectives -Others
Net monetary benefit,Incremental cost- effectiveness ratio,
Cost
Quality of life
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the cost-effectiveness in clinical practice of untreated limited-stage DLBCL.
Net monetary benefit (NMB)
Key secondary outcomes
To clarify the actual condition of treatment outcome, QOL, treatment-related cost and the cost-effectiveness in the limited-stage DLBCL.
Incremental cost-effectiveness ratio (ICER),Overall survival (OS),Progression Free Survival (PFS),
Overall response rate (ORR) of the best overall response in the first treatment period,
Complete response rate (CRR) of the best overall response in the first treatment period,Quality of Life (QOL),Treatment-related cost.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients fulfilling all of the following criteria:
1) Adult patients of 20 years or older at time of registration.
2) Patients who are diagnosed with DLBCL in histopathological diagnosis according to WHO Classification 4th Edition (2008).
3) Treatment naive patients with first episode of DLBCL.
4) Patients in limited-stage of I/IE or II/IIE according to Ann Arbor staging (Cotswolds modification) and without bulky diseases.
5) Patients who are scheduled to undergo R-CHOP therapy.
6) Patients who provided written consents for this study.
Key exclusion criteria
1) Patients with central nervous/meningeal infiltration.
2) Patients with mental illness or impaired cognitive function at time of registration and with difficulty in writing and reading by themselves.
3) Patients with impaired vision at time of registration and with difficulty in writing and reading by themselves.
4) Patients for whom the attending doctor decided not suitable for participation in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | Ota |
| Last name | Tsutsumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Hematology, Clinical research center
Zip code
3113193
Address
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL
029-240-7711
ikuyo.ota@gmail.com
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | Ota |
| Last name | Tsutsumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Hematology , Clinical research center
Zip code
3113193
Address
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL
029-240-7711
Homepage URL
ikuyo.ota@gmail.com
Sponsor or person
Institute
Clinical Hematology Study Group of National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Health Organization Clinical Research Central Ethics Review Board
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
kenkyu2004@hosp.go.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
| 2017 | Year | 03 | Month | 25 | 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
100
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
| 2017 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 09 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
Study design: a prospective cohort study.
Recruitment of subject: all patients who visited the study site during the registration period and fulfill the inclusion criteria.
Registration period: 2 years after the approval of National Hospital Organization Central Research Ethics Committee (hereinafter referred to as the "Central Research Ethics Committee").
Items to be measured:
(1) Characteristics of patients
(2) International prognostic index (IPI)
(3) Stage (according to Ann Arbor classification)
(4) Baseline of lesion site/range
(5) QOL: EQ-5D-5L and EORTC QLQ-C30
(6) Contents of treatment and date of treatment implementation
(7) Determination of therapeutic effect
(8) Adverse events: Grade 3 or more according to CTCAE v4.0-JCOG
Management information
Registered date
| 2017 | Year | 03 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030023
