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Neoadjuvant Chemotherapy vs Chemoradiotherapy in Locally Advanced NSCLC
NCT01054482Phase 2
Key facts
- Status
- Unknown
- Start
- Feb 2007
- Primary completion
- Jan 2011
- Countries
- 1
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Modality
- DNA Intercalators/Alkylators
- Drugs
- docetaxelcarboplatin
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised, open-label trial of docetaxel and carboplatin in non-small cell lung cancer (NSCLC) (2 arms), sponsored by The First Affiliated Hospital of Guangzhou Medical University. Primary endpoint: Time to recurrence. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Pre-operative chemotherapy
Docetaxel 75 mg/m2 + Carboplatin AUC=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
Pre-operative concurrent chemoradiation therapy
Docetaxel 20 mg/m2 + carboplatin AUC=2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles) + Concurrent thoracic radiotherapy
03
Who it enrols
Patients with histopathologically confirmed non-small cell lung cancer, clinical stage IIIA and/or IIIB without pleural effusion, ECOG status 0-1, and adequate organ function.
04
Endpoints
Primary
Time to recurrence
Secondary
Pathologic Complete Response Rate
Complete Resection Rate
Toxicities
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