- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00032175
Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine.
- Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter.
Patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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England
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Bath, England, 영국, BA1 3NG
- Royal United Hospital
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Bournemouth, England, 영국, BH7 7DW
- Royal Bournemouth Hospital
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Bristol, England, 영국, BS2 8ED
- Bristol Haematology and Oncology centre
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Cambridge, England, 영국, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Derby, England, 영국, DE1 2QY
- Derbyshire Royal Infirmary
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Exeter, England, 영국, EX2 5DW
- Royal Devon and Exeter Hospital
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Ipswich, England, 영국, IP4 5PD
- Ipswich Hospital NHS Trust
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King's Lynn, England, 영국, PE30 4ET
- Queen Elizabeth Hospital
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Leeds, England, 영국, LS16 6QB
- Cookridge Hospital at Leeds Teaching Hospital NHS Trust
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Leicester, England, 영국, LE1 5WW
- Leicester Royal Infirmary
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Lincoln, England, 영국, LN2 5QY
- Lincoln County Hospital
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Liverpool, England, 영국, L69 3GA
- Royal Liverpool University Hospital
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Liverpool, England, 영국, L3 9TA
- Cancer Research UK Liverpool Cancer Trials Unit
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London, England, 영국, SE1 7EH
- St. Thomas' Hospital
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Manchester, England, 영국, M20 4BX
- Christie Hospital NHS Trust
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Merseyside, England, 영국, CH63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Middlesbrough, Cleveland, England, 영국, TS4 3BW
- James Cook University Hospital at South Tees Hospitals NHS Trust
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Newcastle-Upon-Tyne, England, 영국, NE4 6BE
- Northern Centre for Cancer Treatment at Newcastle General Hospital
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Norwich, England, 영국, NR4 7UY
- Norfolk and Norwich University Hospital
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Plymouth, England, 영국, PL6 8DH
- Derriford Hospital
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Poole Dorset, England, 영국, BH15 2JB
- Poole Hospital NHS Trust
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Prescot Merseyside, England, 영국, L35 5DR
- Whiston Hospital
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Preston, England, 영국, PR2 9HT
- Royal Preston Hospital
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Salisbury, England, 영국, SP2 8BJ
- Salisbury District Hospital
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Southampton, England, 영국, SO14 0YG
- Royal South Hants Hospital
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Stoke-On-Trent, England, 영국, ST4 7LN
- University Hospital of North Staffordshire
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Sutton, England, 영국, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Warrington, England, 영국, WA5 1QG
- Warrington Hospital NHS Trust
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Scotland
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Aberdeen, Scotland, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
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Wales
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Swansea, Wales, 영국, SA2 8QA
- Singleton Hospital of the Swansea NHS Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas
- Locally advanced or metastatic disease not amenable to curative surgical resection
- Macroscopic residual disease after prior resection with histological confirmation is allowed
- Unidimensionally measurable disease
- No intracerebral metastases or meningeal carcinomatosis
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- WHO 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC greater than 3,000/mm3
- Neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 2 mg/dL
Renal:
- Creatinine less than 2 mg/dL
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No uncontrolled angina pectoris
Other:
- No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other concurrent uncontrolled medical condition
- No other medical or psychiatric condition that would preclude study
- No known hypersensitivity to fluorouracil
- No dihydropyrimidine dehydrogenase deficiency
- No known malabsorption syndromes
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy (including preoperative or adjuvant) for this disease
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy (including preoperative or adjuvant) for this disease
Surgery:
- See Disease Characteristics
Other:
- No prior investigational drugs (including preoperative or adjuvant) for this disease
- No other concurrent investigational drugs
- No concurrent dipyridamole or allopurinol
- No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)
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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1년 생존
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2차 결과 측정
결과 측정 |
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독성
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삶의 질
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객관적 응답률
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Median survival rate
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Survival rate at 2 years
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공동 작업자 및 조사자
수사관
- Emily Owen, Cancer Research UK
간행물 및 유용한 링크
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
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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