NCT00622349

Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 707 (actual)
• Sponsor: European Lung Cancer Working Party · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Cisplatin, Ifosfamide, Gemcitabine	Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
DRUG	Ifosfamide, Gemcitabine	Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
DRUG	Cisplatin, docetaxel	Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-03-01
• Completion: 2009-12-01
• First posted: 2008-02-25
• Last updated: 2013-01-30

Locations

4 sites across 4 countries: Belgium, France, Greece, Spain