- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00560365
Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)
RATIONALE: Following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care.
PURPOSE: This randomized clinical trial is following patients who have undergone surgery for stage I, stage II, or stage III colorectal cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To assess the effect of augmenting symptomatic follow-up in primary care with two intensive methods of follow-up (monitoring tumor marker in primary care and intensive imaging in hospital) on survival of patients with stage I, II, or III colorectal cancer who have undergone curative resection.
Secondary
- Determine the quality of life of these patients.
- Determine the cost of National Health Service (NHS) services utilized.
- Determine the NHS cost per life-year saved.
OUTLINE: This is a multicenter study. Patients are stratified according to certainty of need for imaging follow-up, as determined by the local clinician (uncertain vs certain). Patients are randomized to 1 of 4 follow-up arms.
- Arm I (primary care follow-up): Patients undergo symptomatic follow-up (i.e., are asked to contact their physician if they have symptoms suggestive of disease recurrence). Some patients may also undergo a single CT scan 12-18 months post-randomization.
- Arm II (primary care follow-up): Patients undergo tumor marker measurements (CEA) at baseline, every 3 months for 2 years, and every 6 months for 3 years. Some patients may also undergo a single CT scan 12-18 months post-randomization.
- Arm III (intensive hospital follow-up): Patients undergo CT scan or MRI at baseline, every 6 months for 2 years, and then annually for 3 years.
- Arm IV (primary care and intensive hospital follow-up): Patients undergo primary care and intensive hospital follow-up as in arms II (without the single CT scan) and III.
All patients receive a handbook from their physician detailing possible symptoms suggestive of disease recurrence.
Quality of life is assessed at baseline and then annually for 5 years.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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England
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Burton-upon-Trent, England, 영국, DE13 0RB
- 모병
- Queen's Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1283-566-333
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Carlisle, England, 영국, CA2 7HY
- 모병
- Cumberland Infirmary
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연락하다:
- Contact Person
- 전화번호: 44-1228-523-444
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Chichester, England, 영국, P019 4SE
- 모병
- Saint Richards Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1243-788-122
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Cosham, England, 영국, PO6 3LY
- 모병
- Queen Alexandra Hospital
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연락하다:
- Contact Person
- 전화번호: 44-23-9228-6710
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Cottingham, England, 영국, HU16 5JQ
- 모병
- Castle Hill Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1482-659-331
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Crewe, England, 영국, CW1 4QJ
- 모병
- Mid Cheshire Hospitals Trust- Leighton Hopsital
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연락하다:
- Contact Person
- 전화번호: 44-1270-255-141
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Croydon, England, 영국
- 모병
- Mayday University Hospital
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연락하다:
- Contact Person
- 전화번호: 44-20-8401-3000
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Dartford Kent, England, 영국, DA2 8DA
- 모병
- Darent Valley Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1322-428-500
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Derby, England, 영국, DE22 3NE
- 모병
- Royal Derby Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1332-340-131
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Dudley, England, 영국, DY1 2HQ
- 모병
- Russells Hall Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1384-456-111
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Grantham, Lincolnshire, England, 영국, NG31 8DG
- 모병
- Grantham and District Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1476-565-232
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Harrogate, England, 영국, HG2 7SX
- 모병
- Harrogate District Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1423-885-959
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Harrow, England, 영국, HA1 3UJ
- 모병
- St. Mark's Hospital
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연락하다:
- Contact Person
- 전화번호: 44-20-8235-4000
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High Wycombe, England, 영국
- 모병
- Wycombe General Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1494-426-234
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Huntingdon, England, 영국, PE18 6NT
- 모병
- Hinchingbrooke Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1480-416-416
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Isleworth, England, 영국, TW7 6AF
- 모병
- West Middlesex University Hospital
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연락하다:
- Contact Person
- 전화번호: 44-20-8560-2121
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Leeds, England, 영국, LS1 3EX
- 모병
- Leeds General Infirmary
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연락하다:
- Contact Person
- 전화번호: 44-113-243-2799
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London, England, 영국, W6 8RF
- 모병
- Charing Cross Hospital
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연락하다:
- Contact Person
- 전화번호: 44-20-8846-1234
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Maidstone, England, 영국, ME16 9QQ
- 모병
- Mid Kent Oncology Centre at Maidstone Hospital
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Nottingham, England, 영국, NG7 2UH
- 모병
- Queen's Medical Centre
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연락하다:
- Contact Person
- 전화번호: 44-115-924-9924
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Plymouth, England, 영국, PL6 8DH
- 모병
- Derriford Hospital
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연락하다:
- Contact Person
- 전화번호: 44-175-277-7111
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Scarborough, England, 영국, YO12 6QL
- 모병
- Scarborough General Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1723-342-175
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Shrewsbury, England, 영국, SY3 8XQ
- 모병
- Royal Shrewsbury Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1743-261-000
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Slough, Berkshire, England, 영국, SL2 4HL
- 모병
- Wexham Park Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1753-634-191
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Solihull, England, 영국, B91 2JL
- 모병
- Solihull Hospital
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연락하다:
- Contact Person
- 전화번호: 44-121-424-2000
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Southampton, England, 영국, SO16 6YD
- 모병
- Southampton General Hospital
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Surrey, England, 영국, KT 16 OPZ
- 모병
- St. Peter's Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1932-722-233
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Truro, Cornwall, England, 영국, TR1 3LJ
- 모병
- Royal Cornwall Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1872-250-000
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Uxbridge, England, 영국, UB8 3NN
- 모병
- Hillingdon Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1895-238-282
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Warrington, England, 영국, WA5 1QG
- 모병
- Warrington Hospital NHS Trust
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연락하다:
- Contact Person
- 전화번호: 44-1925-635-911
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Worcester, England, 영국, WR5 1DD
- 모병
- Worcester Royal Hospital
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연락하다:
- Contact Person
- 전화번호: 44-1905-760-719
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of primary colorectal cancer
- Stage I-III disease
Have undergone curative resection (i.e., no residual disease [R0])
- Microscopically clear margins
- Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy
Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL)
- For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy
Has completed primary curative treatment, as deemed by hospital clinician
- Patients awaiting stoma closure allowed
- No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
- No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer
PATIENT CHARACTERISTICS:
- No concurrent serious illness
- History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
- No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
공부 계획
연구는 어떻게 설계됩니까?
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Overall survival by intention-to-treat analysis
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2차 결과 측정
결과 측정 |
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삶의 질
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Cost of National Health Service (NHS) services utilized
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NHS cost per life-year saved
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공동 작업자 및 조사자
수사관
- 연구 의자: John N. Primrose, MD, University Hospital Southampton NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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 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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