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Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

Sponsor
Chonbuk National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02555267
Collaborator
The Catholic University of Korea (Other), Kyungpook National University Hospital (Other), Keimyung University Dongsan Medical Center (Other), Korea University Anam Hospital (Other), Korea University Guro Hospital (Other), Kosin University Gospel Hospital (Other), Pusan National University Hospital (Other), Soonchunhyang University Hospital (Other), Ajou University School of Medicine (Other), Chonnam National University Hospital (Other)
148
Enrollment
1
Location
47
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    148 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Sep 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2017
    Anticipated Study Completion Date :
    Aug 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Elderly patients with DLBCL

    Elderly patients (age>=65 years) with DLBCL treated with R-CHOP chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Overall survival [5 years]

    2. Progression-free survival [5 years]

    3. Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation [1 year]

    Other Outcome Measures

    1. Average received relative 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonbuk National University Hospital Jeonju Korea, Republic of 561-712

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Ho-Young Yhim, MD, PhD, Chonbuk National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ho-Young Yhim, Assistant professor, Chonbuk National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02555267
    Other Study ID Numbers:
    • GERIAD
    First Posted:
    Sep 21, 2015
    Last Update Posted:
    Aug 7, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Ho-Young Yhim, Assistant professor, Chonbuk National University Hospital
    geriatric assessment
    diffuse large B-cell lymphoma
    activity of daily living
    instrumental activity of daily living
    Charlson's comorbidity index
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Aug 7, 2019