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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Angers, 프랑스, 49033
- Centre Hospitalier Regional et Universitaire d'Angers
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Angers, 프랑스, 49036
- Centre Paul Papin
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Bordeaux, 프랑스, 33076
- Institut Bergonie
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Caen, 프랑스, 14076
- Centre Regional Francois Baclesse
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Clamart, 프랑스, 92141
- Hôpital Antoine Béclère
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Corbeil, 프랑스, 91100
- Centre Hospitalier Sud Francilien - Site Corbeil
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Creteil, 프랑스, 94010
- Hôpital Intercommunal de Créteil
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Dijon, 프랑스, 21079
- Centre de Lute Contre le Cancer,Georges-Francois Leclerc
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Dijon, 프랑스, 21034
- Hopital De La Trouhade
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Montbeliard, 프랑스, 25209
- C.H. General Andre Boulloche
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Nantes-Saint Herblain, 프랑스, 44805
- CRLCC Nantes - Atlantique
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Pessac, 프랑스, 33604
- Hopital Haut Lévêque
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Saumur, 프랑스, 49403
- C.H. De Saumur
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Strasbourg, 프랑스, 67091
- Hopitaux Universitaire de Strasbourg
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Toulouse, 프랑스, 31052
- Institut Claudius Regaud
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Vandoeuvre-Les-Nancy, 프랑스, 54511
- CHRU de Nancy - Hôpitaux de Brabois
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Vandoeuvre-les-Nancy, 프랑스, 54511
- Centre Alexis Vautrin
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Villejuif, 프랑스, F-94805
- Institut Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
수사관
- 연구 의자: Thierry L. Le Chevalier, MD, Gustave Roussy, Cancer Campus, Grand Paris
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000065122
- FRE-CPC014
- EU-96009
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