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A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer
This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen
PRIMARY OBJECTIVE: I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy. OUTLINE: Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Syracuse VA Medical Center
Syracuse, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Start Date
January 1, 2010
Primary Completion Date
May 1, 2014
Completion Date
May 1, 2014
Last Updated
July 5, 2018
45
ACTUAL participants
cisplatin
DRUG
carboplatin
DRUG
questionnaire administration
OTHER
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT02889666
NCT02495896
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04056247