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NCT Number: NCT02555267

Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

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.

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Key information

Conditions

Lymphoma, Large B-Cell, Diffuse Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Event-free survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 5 years

  2. Progression-free survival

    Time frame: 5 years

  3. Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation

    Time frame: 1 year

Other outcomes

  1. Average received relative dose intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Sep 21, 2015
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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