Spots Global Cancer Trial Database for Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
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Trial Identification
Brief Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
Official Title: PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
Study ID: NCT00002858
Conditions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France
Centre Paul Papin, Angers, , France
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Hopital Antoine Beclere, Clamart, , France
Centre Hospitalier Sud Francilien - Site Corbeil, Corbeil, , France
Hopital Intercommunal De Creteil, Creteil, , France
Hopital De La Trouhade, Dijon, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon, , France
C.H. General Andre Boulloche, Montbeliard, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Haut Leveque, Pessac, , France
C.H. De Saumur, Saumur, , France
Hopitaux Universitaire de Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
CHRU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Thierry L. Le Chevalier, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: STUDY_CHAIR
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