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

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study ID
NCT01784549
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

* 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.

Key Dates

Start date
Jul 31, 2012
Status verified
Nov 2014
Primary completion
Oct 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cisplatin Docetaxel
    \- Cisplatin + Docetaxel day 1 q 21 days for 3 cycles
  • Experimental: Gefitinib Pemetrexed Vinorelbine Gemcitabine
    * Gefitinib day for 8 wks; * Pemetrexed day 1 q 21 days for 3 cycles; * Docetaxel day 1 + Vinorelbine days 1,8 q 21 days for 3 cycles; * Docetaxel days 1,8 + Gemcitabine days 1,8 q 21 days for 3 cycles; * Cisplatin + Docetaxel day 1 q 21 days for 3 cycles; * Cisplatin day 1+ Gemcitabine days 1,8 q 21 days for 3 cycles;

Primary Outcome Measure

Pathologic Complete Response [ Time Frame: 30 days ]

Central Contacts

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