- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01836653
Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Tokyo
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Shinjuku-ku, Tokyo, 일본, 162-0814
- EPS Corporation
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
- RAS wild type
Synchronous* or metachronous liver limited meitastasis with no extrahepatic desiease
- shychronous liver limited metastasis with primary lesion less than two thirds of the circumference
- patients with primary lesion more than two thirds of the circumference can be enrolled after primary resection
- Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT or contrast enhanced MRI of the liver:
(1)Liver metastases 5 or more (2)Liver metastases with 5 cm or larger in greatest dimension (3)Unresectable considering remaining hepatic function (4)Invasion into all hepatic veins or inferior vena cava (5)Invasion into both right and left hepatic arteries or portal veins 5.No prior chemotherapy for colorectal cancer including hepatic arterial infusion. Excluding postoperative and preoperative chemoradiotherapy except for rectal cancer with synchronous liver metastases. Patients received postoperative chemotherapy containing oxaliplatin have to be enrolled after 24 weeks from the last oxaliplatin administration.
6.No previous treatment including ablation therapy, cryotherapy and chemotherapy for metastases 7.Age at enrollment is >=20 and =<80 years 8.The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 9.Life expectancy from the day of enrollment is 3 months or longer 10.Major organ functions less than 14 days prior to entry meet the following criteria.
- Neu >= 1500/mm3
- Pt >= 10.0x10^4/mm3
- Hb >= 9.0 g/dL
- T-bil =< 2.0 mg/dL
- AST and ALT =< 200 IU/L
- sCr =< 1.20 mg/dL
- INR < 1.5
- Proteinuria =< 2+ 11.Written informed consent
Exclusion Criteria:
- Previously experienced severe allergic reaction to drugs
- Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
- Receiving chronic systemic corticosteroid treatment
- Surgery/ biopsy with skin incision or traumatic injury with suture less than 14 days prior to entry. Excluding, suture for implanted venous reservoirs with catherter is allowed.
- Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
- Diagnosed as hereditary colorectal cancer
- Active other malignancies
- Cerebrovascular disease or symptoms less than 1 year prior to entry
- Pleural effusion, ascites or cardiac effusion requiring drainage
- Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
- Perforation of gastrointestinal tract less than 1 year prior to entry
- Presence of active infection
- HBs antigen or HCV antibody positive
- Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
- Presence of >= grade 2 diarrhea
- Presence of >= grade 1 peripheral neuropathy
- Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
- Psychosis or psychiatric symptoms who are not able to comply with the protocol
- Any other medical conditions disable to comply with the protocol
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 |
|---|---|
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실험적: mFOLFOX + Bmab
mFOLFOX plus bevacizumab
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5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
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활성 비교기: mFOLFOX + Cmab
mFOLFOX plus cetuximab
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85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free survival
기간: assessed every 8 weeks, up to 4 years
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assessed by Independent Review Committee
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assessed every 8 weeks, up to 4 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Response rate
기간: assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tumor shrinkage rate at 8 week
기간: assessed at 8 week, up to 8 weeks
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assessed at 8 week, up to 8 weeks
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Liver resection rate
기간: assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
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|
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R0 liver resection rate
기간: assessed every 8 weeks, up to 4 years
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pathologically confirmed R0 liver resection rate
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assessed every 8 weeks, up to 4 years
|
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Progression-free survival
기간: assessed every 8 weeks, up to 4 years
|
assessed by investigators
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assessed every 8 weeks, up to 4 years
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|
Time to treatment-failure
기간: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
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Overall survival
기간: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
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Quality of life
기간: assessed every 16 weeks, up to 1 year
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assessed every 16 weeks, up to 1 year
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Incidence of adverse events
기간: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
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Progression-free survival among the RAS wild type subpopulation
기간: assessed every 8 weeks, up to 4 years
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All the assessment is repeated for a maximum of 4 years.
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assessed every 8 weeks, up to 4 years
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Yoshihiko Maehara, MD,PhD,FACS, Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- 수석 연구원: Naohiro Tomita, MD, PhD, Hyogo College of Medicine, Department of Surgery
- 수석 연구원: Ichinosuke Hyodo, MD, PhD, Tsukuba University, Graduate School of Medicine
- 수석 연구원: Michiaki Unno, MD, PhD, Tohoku University, Division of Gastroenterological Surgery
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ATOM (Radius Health, Inc.)
- UMIN000010209 (기타 식별자: UMIN)
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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