Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)

This study is not yet open for participant recruitment.

See

Contacts and Locations

Verified July 2017 by Ho-Young Yhim, Chonbuk National University Hospital

Sponsor:

Collaborators:

The Catholic University of Korea

Kyungpook National University

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

Chungnam National University Hospital

Yeungnam University Hospital

Information provided by (Responsible Party):

Ho-Young Yhim, Chonbuk National University Hospital

ClinicalTrials.gov Identifier:

NCT03211702

First received: July 6, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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.

Condition
Lymphoma, Large B-cell, Diffuse


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: B-cell Lymphoma Diffuse Large B-Cell Lymphoma Lymphosarcoma

U.S. FDA Resources

Further study details as provided by Ho-Young Yhim, Chonbuk National University Hospital:

Primary Outcome Measures:

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 Outcome Measures:

Overall survival [ Time Frame: 5 years ]
Progression-free survival [ Time Frame: 5 years ]
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation [ Time Frame: 1 year ]

Other Outcome Measures:

Average received ralative 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.


Estimated Enrollment:	100
Anticipated Study Start Date:	August 2017
Estimated Study Completion Date:	August 2021
Estimated Primary Completion Date:	August 2019 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211702

Contacts


Contact: Ho-Young Yhim	82-63-250-2523	yhimhy@naver.com
Contact: Deok-Hwan Yang	82-61-379-7636	drydh1685@hotmail.com

Sponsors and Collaborators

Chonbuk National University Hospital