- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003696
Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer.
- Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks.
- Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks.
Patients with stable or responding disease are treated for up to 5 courses.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1007 MB
- Vrije Universiteit Medisch Centrum
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases
Measurable or evaluable disease
- Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases)
Renal:
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No cardiac failure or rhythm disturbances requiring medication
Other:
- No history of hypersensitivity to castor oil
- No active uncontrolled infection
- No nonmalignant disease presenting a poor medical risk
- Not pregnant
- Fertile patients must use effective contraception during and for 3 months after the study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field)
Surgery:
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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무진행 생존
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2차 결과 측정
결과 측정 |
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독성
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응답률
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전반적인 생존
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응답 기간
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공동 작업자 및 조사자
수사관
- 연구 의자: Egbert F. Smit, MD, Free University Medical Center
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
- CDR0000066803
- CKVO-9802
- DUT-KWF-CKVO-9802
- EU-98059
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