Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT00004100
• Lead Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Compare gemcitabine plus vinorelbine vs standard chemotherapy containing cisplatin in terms of the effect on the quality of life of patients with stage IIIB or IV non-small cell lung cancer. II. Compare the effect of these regimens on the overall survival of these patients. III. Compare the toxic effects of these regimens in these patients. IV. Compare the effect of these regimens on the rate of objective response in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and either gemcitabine IV or vinorelbine IV on days 1 and 8. Arm II: Patients receive gemcitabine IV and vinorelbine IV on days 1 and 8. Treatment repeats every 21 days for up to 6 courses. Quality of life is assessed prior to therapy and before each course of chemotherapy to the fourth course.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-11
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2004-04-15
• Study First Posted: 2004-04-16
• Status Verified: 2008-06
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (29)

Ospedale San Lazzaro; 🇮🇹 Alba, Italy

Ospedale Civile Avellino; 🇮🇹 Avellino, Italy

Ospedale G. Di Maria - Avola (SR); 🇮🇹 Avola (SR), Italy

Ospedale Maggiore Lodi; 🇮🇹 Lodi, Italy

Ospedale Civile Cosenza; 🇮🇹 Cosenza, Italy

Ospedale San Carlo Borromeo; 🇮🇹 Milan, Italy

Federico II University Medical School; 🇮🇹 Naples, Italy

Ospedale S. Gennora USL 42; 🇮🇹 Naples, Italy

Ospedale Vincenzo Monaldi; 🇮🇹 Napoli, Italy

ASL 2 - Napoli; 🇮🇹 Napoli, Italy

Ospedale S. Francesco - Paola; 🇮🇹 Paola (CS), Italy

Ospedale Oncologieo G. Fortunato; 🇮🇹 Rionero, Italy

Ospedale San Martino/Cliniche Universitarie Convenzionate; 🇮🇹 Genoa, Italy

Azienda Ospedaliena G. Rummo; 🇮🇹 Benevento, Italy

Ospedale Cardarelli - Campobasso; 🇮🇹 Campobasso, Italy

Ospedale Gen. Provinciale Santa Maria Goretti; 🇮🇹 Latina, Italy

Ospedale di Legnano; 🇮🇹 Legnano, Italy

Istituto Di Science Biomediche San Paolo; 🇮🇹 Milano, Italy

Ospedale Di Gabargnate Milanese; 🇮🇹 Milan, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Naples, Italy

Universita di Palermo; 🇮🇹 Palermo, Italy

Ospedale La Maddalena - Palermo; 🇮🇹 Palermo, Italy

Ospedale Agnelli; 🇮🇹 Pinerolo, Italy

Istituti Fisioterapici Ospitalieri - Roma; 🇮🇹 Rome, Italy

Ospedali Riuniti; 🇮🇹 Reggio Calabria, Italy

U.S.S.L. 33; 🇮🇹 Rho, Italy

Ospedale San Carlo; 🇮🇹 Potenza, Italy

Ospedale Civile - Rovereto; 🇮🇹 Rovereto, Italy

Ospedale San Bortolo; 🇮🇹 Vicenza, Italy