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Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase 3
Completed
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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (33)

Catharina Ziekenhuis

🇳🇱

Eindhoven, Netherlands

Ziekenhuis de Heel

🇳🇱

Zaandam, Netherlands

Ospedale San Giovanni

🇨🇭

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

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