Metadata
- Name
- Customized Neoadjuvant Versus Standard Chemotherapy in NSCL Patients With Resectable Stage IIIA (N2)Disease
- Repository
- ClinicalTrials.gov
- Identifier
- clinicaltrials:NCT01784549
- Description
- - 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. - Data or Study Types
- clinical trial
- Keywords
- NSCL, Customized Neoadjuvant Therapy, biomarkers
- Source Organization
- Unknown
- Access Conditions
- available
- Year
- 2013
- Access Hyperlink
- https://clinicaltrials.gov/ct2/show/NCT01784549
Distributions
- Encoding Format: HTML ; URL: https://clinicaltrials.gov/ct2/show/results/NCT01784549