Customized Neoadjuvant Versus Standard Chemotherapy in NSCL Patients With Resectable Stage IIIA (N2)Disease
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
- The investigators hypothesized that NSCL patients receiving therapy based on their
baseline tumor markers levels would attain higher response rates than patients in the
control arm receiving non customized therapy.
- patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized
therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard
chemotherapy.
- The primary objective of this multicenter trial is to compare pathological complete
response of all subjects randomized, by treatment arm.
- Secondary objectives are to compare all randomized subjects by treatment arm for:
response rate, disease-free survival, overall survival, one, two and three year survival
and safety profile.
The study is expected to demonstrate both the feasibility of this approach and the logistic
problems associated with a biomarker-driven therapeutic strategy in NSCLC.
Phase:
Phase 2
Details
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborators:
ASL TO4, Chivasso Azienda Ospedaliera "Sant'Andrea" Azienda Ospedaliera dei Colli Azienda Ospedaliera dei Colli Monaldi-Cotugno-CTO, Napoli Azienda Ospedaliera S. Maria della Misericordia Azienda Ospedaliera San Camillo Forlanini Azienda Ospedaliera San Gerardo di Monza Azienda Ospedaliera San Giovanni Battista Azienda Ospedaliera Sant'Andrea, Roma Azienda Ospedaliera Santa Maria Degli Angeli Azienda Ospedaliera Spedali Riuniti di Livorno, Livorno Azienda Ospedaliera Universitaria Integrata Verona Azienda Ospedaliera, Ospedale Civile di Legnano Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento Azienda Sanitaria Locale di Cagliari Azienda Sanitaria Locale n.2 Savonese Istituto Clinico Humanitas Istituto Tumori Giovanni Paolo II, BARI Ospedale Santa Croce-Carle Cuneo