Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)

Chonbuk National University Hospital2 sites in 1 country100 target enrollmentAugust 25, 2017

ConditionsLymphoma, Large B-cell, Diffuse

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lymphoma, Large B-cell, Diffuse
Sponsor: Chonbuk National University Hospital
Enrollment: 100
Locations: 2
Primary Endpoint: Event-free survival
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 25, 2017

End Date

December 30, 2020

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Chonbuk National University Hospital

Responsible Party

Principal Investigator

Ho-Young Yhim

Assistant professor

Chonbuk National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Overall survival(5 years)
Progression-free survival(5 years)
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation(1 year)