Lymphoma, Large B-cell, Diffuse Clinical Trial
Official title:
Multi-center, Prospective Cohort Study to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP
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 |
Verified date | February 2023 |
Source | Chonbuk National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonbuk National University Hospital | Jeonju |
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 |
Korea, Republic of,
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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