- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00053820
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.
- Compare the toxicity of these regimens in these patients.
- Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.
Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Leiden, 네덜란드, 2300 CA
- Leiden University Medical Center
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Maastricht, 네덜란드, 6202 AZ
- Academisch Ziekenhuis Maastricht
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Nijmegen, 네덜란드, 6500 HB
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam, 네덜란드, 3000 CA
- University Medical Center Rotterdam at Erasmus Medical Center
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Rotterdam, 네덜란드, 3015 GJ
- Erasmus MC - Sophia Children's Hospital
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Kassel, 독일, D-34125
- Klinikum Kassel
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Aalst, 벨기에, B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels, 벨기에, 1000
- Institut Jules Bordet
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Brussels, 벨기에, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Edegem, 벨기에, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, 벨기에, B-3000
- U.Z. Gasthuisberg
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Bratislava, 슬로바키아, 833 10
- National Cancer Institute - Bratislava
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
- Advanced metastatic disease that requires treatment
- Measurable disease (single bone lesions not included)
- No brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 to 81
Performance status
- WHO 0-1
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable angina pectoris
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- No other concurrent disease or prior malignancy that would preclude study treatments or comparisons
- No concurrent active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Prior resection of the primary tumor recommended but not required
- No prior major organ allografts
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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활착
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2차 결과 측정
결과 측정 |
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Time to progression as measured by RECIST criteria
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Comparison of toxicity levels (Grade III and IV)
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Comparison of quality of life before, during, after completion of study treatment
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Impact of the treatment regimens on health economics
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공동 작업자 및 조사자
수사관
- Martin E. Gore, MD, Royal Marsden NHS Foundation Trust
- Peter F.A. Mulders, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen
간행물 및 유용한 링크
일반 간행물
- Gore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, James N, Oliver RT, Mardiak J, Hussain T, Sylvester R, Parmar MK, Royston P, Mulders PF. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet. 2010 Feb 20;375(9715):641-8. doi: 10.1016/S0140-6736(09)61921-8. Epub 2010 Feb 10.
- Gore ME: Interferon-α (IFN), interleukin-2 (IL2) and 5-fluorouracil (5FU) vs IFN alone in patients with metastatic renal cell carcinoma (mRCC): results of the randomised MRC/EORTC RE04 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-5039, 2008.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
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
- CDR0000269480
- MRC-RE04
- EORTC-30012
- EU-20231
- ISRCTN46518965
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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