Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00003589
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I), gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with advanced non-small cell lung cancer. II. Determine the response rate, duration of response, progression-free survival, toxicity, and quality of life of these patients randomized in these three treatment arms.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity and disease progression, patients may receive up to 6 courses of treatment. Quality of life is assessed before, during, and at the end of treatment, then every 6 weeks until disease progression, and then every 3 months until death. Patients are followed every 6 weeks until disease progression, then every 3 months until death.
PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this study over 36 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Ziekenhuis de Heel
🇳🇱Zaandam, Netherlands
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Leiden University Medical Center
🇳🇱Leiden, Netherlands
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
University Hospital Bulovka
🇨🇿Krhanice, Czech Republic
Hippokration General Hospital of Athens
🇬🇷Athens, Greece
Leyenburg Ziekenhuis
🇳🇱's-Gravenhage (Den Haag, The Hague), Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Rijnland Ziekenhuis
🇳🇱Leiderdorp, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Academisch Ziekenhuis Utrecht
🇳🇱Utrecht, Netherlands
St. Maartens Gasthuis
🇳🇱Venlo, Netherlands
Sophia Ziekehuis
🇳🇱Zwolle, Netherlands
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Gelre Ziekenhuizen - Lokatie Lukas
🇳🇱Apeldoorn, Netherlands
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
Elkerliek Ziekenhuis
🇳🇱Helmond, Netherlands
Sint Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
University Hospital - Rotterdam Dijkzigt
🇳🇱Rotterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Ziekenhuis St Jansdal
🇳🇱Harderwijk, Netherlands
Thoraxklinik Rohrbach
🇩🇪Heidelberg, Germany
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
CHRU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Ospedale degli Infermi
🇮🇹Biella, Italy
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱's-Hertogenbosch, Netherlands
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
Ziekenhuis de Baronie
🇳🇱Breda, Netherlands
Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
Maritime Hospital
🇵🇱Gdynia, Poland
Hospital Universitario de Getafe
🇪🇸Madrid, Spain