NCT03211702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

July 6, 2017

Last Update Submit

February 2, 2023

Conditions

Lymphoma, Large B-cell, Diffuse

Keywords

geriatric assessmentsdiffuse large B-cell lymphomaactivity of daily livinginstrumental activity of daily livingCharlson's comorbidity index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall survival

    5 years

  • Progression-free survival

    5 years

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

    1 year

Other Outcomes (1)

  • Average received ralative dose intensity

    6 months

Study Arms (1)

Elderly DLBCL patients

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

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly DLBCL patients (≥ 65 years) treated with R-CHOP

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 7, 2017

Study Start

August 25, 2017

Primary Completion

April 30, 2018

Study Completion

December 30, 2020

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)