The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchial Neoplasms
- Carcinoma, Bronchogenic
- Lung Diseases
- Lung Neoplasms
- Neoplasms
- Respiratory Tract Diseases
- Respiratory Tract Neoplasms
- Stage IV NSCLC
- Thoracic Neoplasms
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 70 years and 125 years
- Gender
- Both males and females
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 inclusion/exclusion criteria to be eligible....
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 inclusion/exclusion 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 patient's diagnosis and staging. Patients will be randomized to either Arm A: Experimental or Arm B: Standard of Care in a 2:1 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.
Tracking Information
- NCT #
- NCT03402048
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Silvia Novello, MD, PhD University of Turin, Italy Principal Investigator: Giorgio Vittorio Scagliotti, MD, PhD Univerisity of Turin Principal Investigator: Tiziana Vavalà, MD University of Turin, Italy