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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name