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.

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. - NHOH-CUA-DLBCL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026684

Enrollment

200

Registered

2017-03-25

Start date

2017-03-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated limited-stage DLBCL

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To clarify the cost-effectiveness in clinical practice of untreated limited-stage DLBCL. Net monetary benefit (NMB)	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactIkuyo Tsutsumi

National Hospital Organization Mito Medical Center Department of Hematology , Clinical research center

ikuyo.ota@gmail.com029-240-7711

Outcome results