Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT00002858
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.

Detailed Description

OBJECTIVES: I. Compare the effect on 2-year disease-free survival of two different doses of cyclophosphamide as part of first induction chemotherapy followed by alternating chemotherapy and chest irradiation in patients with limited stage small cell lung cancer.

OUTLINE: This is a randomized study. Patients are stratified by participating institution. All patients receive 2 courses of induction chemotherapy with doxorubicin, etoposide, cisplatin, and cyclophosphamide. For the first course, one group of patients receives a lower dose of cyclophosphamide than the other group. Both groups receive the same, and still lower, dose of cyclophosphamide during the second course. Beginning 1 week after the completion of induction therapy, patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction. Each course is initiated after a 1-week rest. Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course. Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 280 patients will be entered.

Study Timeline

• Study Start: 1993-03
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-03-11
• Study First Posted: 2004-03-12
• Status Verified: 2007-05
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (19)

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

CHRU de Nancy - Hopitaux de Brabois; 🇫🇷 Vandoeuvre-Les-Nancy, France

C.H. De Saumur; 🇫🇷 Saumur, France

Centre Hospitalier Regional et Universitaire d'Angers; 🇫🇷 Angers, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier Sud Francilien - Site Corbeil; 🇫🇷 Corbeil, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Hopital Antoine Beclere; 🇫🇷 Clamart, France

Hopital Intercommunal De Creteil; 🇫🇷 Creteil, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Hopital De La Trouhade; 🇫🇷 Dijon, France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc; 🇫🇷 Dijon, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

C.H. General Andre Boulloche; 🇫🇷 Montbeliard, France

Hopitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France