Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03402048
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2014-11-17
Brief Title:
The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief Summary:
This is a randomized phase III trial that will randomize elderly patients70 years of age and older who are not considered eligible for standard doublet or triplet regimens In a 21 fashion patients will be randomized to the customization arm or the standard arm respectively This trial will be offered to patients who are previously untreated for stage IV NSCLC
The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1 RRM1 and TS arm A the experimental arm results in superior outcome in elderly patients with untreated advanced NSCLC compared to standard of care treatments arm B the standard arm
The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1 RRM1 and TS arm A the experimental arm results in superior outcome in elderly patients with untreated advanced NSCLC compared to standard of care treatments arm B the standard arm
Detailed Description:
The study population will consist of patients with histologically or cytologically proven stage IV NSCLC who have not been previously treated with chemotherapy for stage IV and are either elderly 70 years of age and older Patients must fulfill all the inclusionexclusion criteria to be eligible
Tissue will be obtained and gene expression analysis will be performed at the University of Turin The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patients diagnosis and staging Patients will be randomized to either Arm A Experimental or Arm B Standard of Care in a 21 fashion
Tissue will be obtained for gene analysis for ALL patients However ONLY patients randomized to Arm A will receive the genetic analysis results Genetic results will not be disclosed to the registering center for those patients randomized to Arm B Standard of Care
For patients randomized to Arm A Experimental arm the chemotherapy treatment prescription will be based on the gene analysis according to the protocol For patients randomized to Arm B Standard of Care arm the chemotherapy treatment will be at the discretion of the care provider
Tissue will be obtained and gene expression analysis will be performed at the University of Turin The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patients diagnosis and staging Patients will be randomized to either Arm A Experimental or Arm B Standard of Care in a 21 fashion
Tissue will be obtained for gene analysis for ALL patients However ONLY patients randomized to Arm A will receive the genetic analysis results Genetic results will not be disclosed to the registering center for those patients randomized to Arm B Standard of Care
For patients randomized to Arm A Experimental arm the chemotherapy treatment prescription will be based on the gene analysis according to the protocol For patients randomized to Arm B Standard of Care arm the chemotherapy treatment will be at the discretion of the care provider
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None