Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
NCT ID: NCT00002858
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
1993-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Under 70 Performance status: Karnofsky 60%-100% Hematopoietic: WBC greater than 2,000 Platelets greater than 125,000 Hepatic: Not specified Renal: Creatinine less than 1.1 mg/dL (100 micromoles/L) Cardiovascular: No myocardial infarction within 6 months No other cardiovascular disease that precludes protocol treatment Other: No hearing loss No prior or concurrent malignancy except: Basal cell skin carcinoma In situ carcinoma of the cervix Accessible for follow-up
PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or surgery
69 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Thierry L. Le Chevalier, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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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
Créteil, , France
Hopital De La Trouhade
Dijon, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , France
C.H. General Andre Boulloche
Montbéliard, , 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
Vandœuvre-lès-Nancy, , France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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FRE-CPC014
Identifier Type: -
Identifier Source: secondary_id
EU-96009
Identifier Type: -
Identifier Source: secondary_id
CDR0000065122
Identifier Type: -
Identifier Source: org_study_id
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