Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)

Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03211702

Enrollment

100

Registered

2017-07-07

Start date

2017-08-25

Completion date

2020-12-30

Last updated

2023-02-03

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

Conditions

Lymphoma, Large B-cell, Diffuse

Keywords

geriatric assessments, diffuse large B-cell lymphoma, activity of daily living, instrumental activity of daily living, Charlson's comorbidity index

Brief summary

This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Inclusion criteria

* Patients with newly diagnosed CD20+ DLBCL * 65 years old or over * Scheduled to receive R-CHOP chemotherapy * Informed consent

Exclusion criteria

* Other histology than CD20+ DLBCL * Primary central nervous system DLBCL * Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer \[papillary or follicular thyroid cancer\]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry * Consent withdrawal

Design outcomes

Primary

Measure	Time frame	Description
Event-free survival	2 years	Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments

Secondary

Measure	Time frame
Overall survival	5 years
Progression-free survival	5 years
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation	1 year

Other

Measure	Time frame	Description
Average received ralative dose intensity	6 months	The dose intensity of each agent of R-CHOP chemotherapy was calculated by dividing the total received dose of the agent by the number of weeks of treatment. The relative dose intensity of each agents then was calculated by dividing the received dose intensity by the projected dose intensity for the agent. The sum of the relative dose intensities of the individual agents was divided by the number of agents in the R-CHOP to yield the average received relative dose intensity. In this study the average received relative dose intensity is calculated.

Countries

South Korea

Outcome results