Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Angers, Frankrike, 49033
- Centre Hospitalier Regional et Universitaire d'Angers
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Angers, Frankrike, 49036
- Centre Paul Papin
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Bordeaux, Frankrike, 33076
- Institut Bergonie
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Caen, Frankrike, 14076
- Centre Regional Francois Baclesse
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Clamart, Frankrike, 92141
- Hôpital Antoine Béclère
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Corbeil, Frankrike, 91100
- Centre Hospitalier Sud Francilien - Site Corbeil
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Creteil, Frankrike, 94010
- Hôpital Intercommunal de Créteil
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Dijon, Frankrike, 21079
- Centre de Lute Contre le Cancer,Georges-Francois Leclerc
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Dijon, Frankrike, 21034
- Hopital De La Trouhade
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Montbeliard, Frankrike, 25209
- C.H. General Andre Boulloche
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Nantes-Saint Herblain, Frankrike, 44805
- CRLCC Nantes - Atlantique
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Nice, Frankrike, 06189
- Centre Antoine Lacassagne
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Pessac, Frankrike, 33604
- Hopital Haut Lévêque
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Saumur, Frankrike, 49403
- C.H. De Saumur
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Strasbourg, Frankrike, 67091
- Hopitaux Universitaire de Strasbourg
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Toulouse, Frankrike, 31052
- Institut Claudius Regaud
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Vandoeuvre-Les-Nancy, Frankrike, 54511
- CHRU de Nancy - Hôpitaux de Brabois
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Vandoeuvre-les-Nancy, Frankrike, 54511
- Centre Alexis Vautrin
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Villejuif, Frankrike, F-94805
- Institut Gustave Roussy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically proven small cell lung cancer with no distant metastases Size of initial lesion suitable for total irradiation Positive subclavicular nodes allowed No malignant pleural effusion No extension into contralateral lung
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Thierry L. Le Chevalier, MD, Gustave Roussy, Cancer Campus, Grand Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Småcellet lungekarsinom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Cyklofosfamid
- Etoposid
- Cisplatin
- Doxorubicin
- Liposomal doksorubicin
Andre studie-ID-numre
- CDR0000065122
- FRE-CPC014
- EU-96009
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