Customized Neoadjuvant Versus Standard Chemotherapy in NSCL Patients With Resectable Stage IIIA (N2)Disease

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

DRUG

Cisplatin Docetaxel Gefitinib Pemetrexed Vinorelbine Gemcitabine

Sponsors & Collaborators

• Azienda Sanitaria Locale di Cagliari

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Ospedale Santa Croce-Carle Cuneo

  collaborator OTHER

• Azienda Ospedaliera S. Maria della Misericordia

  collaborator OTHER

• Istituto Tumori Giovanni Paolo II, BARI

  collaborator UNKNOWN

• Azienda Ospedaliera dei Colli Monaldi-Cotugno-CTO, Napoli

  collaborator UNKNOWN

• Azienda Ospedaliera Santa Maria Degli Angeli

  collaborator OTHER

• Azienda Ospedaliera San Camillo Forlanini

  collaborator OTHER

• Azienda Ospedaliera San Giovanni Battista

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  collaborator OTHER

• Azienda Sanitaria Locale n.2 Savonese

  collaborator OTHER

• ASL TO4, Chivasso

  collaborator UNKNOWN

• Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Azienda Ospedaliera "Sant'Andrea"

  collaborator OTHER

• Azienda Ospedaliera, Ospedale Civile di Legnano

  collaborator OTHER

• Azienda Ospedaliera Spedali Riuniti di Livorno, Livorno

  collaborator UNKNOWN

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  lead OTHER

Principal Investigators

• Francesco Grossi, MD · IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2015-10-31

Completion

2015-12-31

Countries

• Italy

Study Locations