- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00482222
Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer
A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.
연구 개요
상태
상세 설명
OBJECTIVES:
Primary
- Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the cost effectiveness of these regimens in these patients.
OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.
Neoadjuvant therapy:
Arm I: Patients receive 1 of the following chemotherapy regimens:
- OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive 1 of the following regimens:
- OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection.
Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy.
- Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter.
Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
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England
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Basildon, England, 영국, SS16 5NL
- 모병
- Basildon University Hospital
-
연락하다:
- Pauline Leonard, MD
- 전화번호: 44-1702-435-555
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Basingstoke, England, 영국, RG24 9NA
- 모병
- Basingstoke and North Hampshire NHS Foundation Trust
-
연락하다:
- Charlotte Rees, MD
- 전화번호: 44-125-631-4793
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Bournemouth, England, 영국, BH7 7DW
- 모병
- Royal Bournemouth Hospital
-
연락하다:
- Tamas Hickish, MD
- 전화번호: 44-1202-303-626
- 이메일: tamas.hickish@rbch.nhs.uk
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Cambridge, England, 영국, CB2 0QQ
- 모병
- Addenbrooke's Hospital
-
연락하다:
- Pippa Corrie, PhD, FRCP
- 전화번호: 44-1223-274-401
- 이메일: pippa.corrie@addenbrookes.nhs.uk
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Guildford, England, 영국, GU2 7XX
- 모병
- St. Luke's Cancer Centre at Royal Surrey County Hospital
-
연락하다:
- Sharadah Essapen, MD
- 전화번호: 44-1483-571-122
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Liverpool, England, 영국, L9 7AL
- 모병
- Aintree University Hospital
-
연락하다:
- Graeme J. Poston, MD
- 전화번호: 44-151-525-5980
- 이메일: graeme.poston@aintree.nhs.uk
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Liverpool, England, 영국, L9 7AL
- 모병
- Royal Liverpool University Hospital
-
연락하다:
- Paula Ghaneh, MD
-
London, England, 영국, SW3 6JJ
- 모병
- Royal Marsden - London
-
연락하다:
- David Cunningham, MD
- 전화번호: 44-20-8661-3156
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London, England, 영국, EC1A 7BE
- 모병
- Saint Bartholomew's Hospital
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London, England, 영국, W6 8RF
- 모병
- Charing Cross Hospital
-
연락하다:
- Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR
- 전화번호: 44-208-383-0576
- 이메일: charles.lowdell@imperial.nhs.uk
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London, England, 영국, NW3 2PF
- 모병
- UCL Cancer Institute
-
연락하다:
- Astrid Mayer, MD
- 전화번호: 44-207-794-0500
- 이메일: a.mayer@ucl.ac.uk
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Merseyside, England, 영국, CH63 4JY
- 모병
- Clatterbridge Centre For Oncology
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Newport, England, 영국, PO30 5TG
- 모병
- St. Mary's Hospital
-
연락하다:
- Christopher Baughan, MD
- 전화번호: 44-1983-524-081
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Nottingham, England, 영국, NG5 1PB
- 모병
- Cancer Research Centre at Weston Park Hospital
-
연락하다:
- J. Hornbuckle, MD
- 전화번호: 44-115-969-1169 ext. 47599
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Poole Dorset, England, 영국, BH15 2JB
- 모병
- Dorset Cancer Centre
-
연락하다:
- Tamas Hickish, MD
- 전화번호: 44-1202-442-532
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Salisbury, England, 영국, SP2 8BJ
- 모병
- Salisbury District Hospital
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Southampton, England, 영국, SO16 6YD
- 모병
- Southampton General Hospital
-
연락하다:
- John N. Primrose, MD
- 전화번호: 44-23-8079-6144
- 이메일: j.n.primrose@soton.ac.uk
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Sutton, England, 영국, SM2 5PT
- 모병
- Royal Marsden - Surrey
-
Westcliff-On-Sea, England, 영국, SS0 0RY
- 모병
- Southend University Hospital NHS Foundation Trust
-
연락하다:
- Pauline Leonard, MD
- 전화번호: 44-1702-435-555
-
Worthing, England, 영국, BN11 2DH
- 모병
- Worthing Hospital
-
연락하다:
- Andrew Webb, MD
- 전화번호: 44-1903-205-111
-
-
Wales
-
Cardiff, Wales, 영국, CF14 2TL
- 모병
- Velindre Cancer Center at Velindre Hospital
-
연락하다:
- Timothy Maughan, MD
- 전화번호: 44-2920-316-904
-
Cardiff, Wales, 영국, CF14 4XW
- 모병
- University Hospital of Wales
-
연락하다:
- Timothy Maughan, MD
- 전화번호: 44-2920-316-904
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum
- Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied
Must have potentially resectable liver metastases present, as defined by any of the following:
- Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)
- Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry
- Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months
- Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)
- No detectable extrahepatic tumor that cannot be completely resected
- Unidimensionally measurable disease
- No brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- WBC ≥ 4,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count > 150,000/mm³
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- AST or ALT ≤ 3 times ULN
- Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No psychiatric or neurological condition that would preclude study compliance
- No partial or complete bowel obstruction
- No preexisting neuropathy > grade 1
- No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment
- No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment
- No known hypersensitivity reaction to any of the components of the study drugs
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for metastatic disease
- More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride
- More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium
- No concurrent contraindicated medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: OxMdG / IrMdG chemotherapy
OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks
|
|
실험적: OxMdG / IrMdG chemotherapy with cetuximab
OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Progression-free survival
기간: end of study
|
end of study
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
전반적인 생존
기간: 연구의 끝
|
연구의 끝
|
Response rate before surgery as assessed by RECIST criteria
기간: end of study
|
end of study
|
Pathological resection status
기간: end of study
|
end of study
|
Toxicity
기간: end of study
|
end of study
|
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
기간: end of study
|
end of study
|
Cost effectiveness
기간: end of study
|
end of study
|
Safety
기간: end of study
|
end of study
|
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000549541
- USCTU-4351
- USCTU-EPOC
- EUDRACT-2006-003121-82
- ISRCTN22944367
- EU-20732
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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