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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02555267
Other study ID # GERIAD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date December 2020

Study information

Verified date February 2023
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigate 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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date December 2020
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Korea, Republic of Chonbuk National University Hospital Jeonju

Sponsors (11)

Lead Sponsor Collaborator
Chonbuk National University Hospital Ajou University School of Medicine, Chonnam National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Kyungpook National University Hospital, Pusan National University Hospital, Soonchunhyang University Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Average received relative dose intensity 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. 6 months
Primary Event-free survival Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments 2 years
Secondary Overall survival 5 years
Secondary Progression-free survival 5 years
Secondary Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation 1 year
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