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
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Tokyo
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Shinjuku-ku、Tokyo、日本、162-0814
- EPS Corporation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
其他名称:
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.
其他名称:
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.
其他名称:
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.
其他名称:
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.
其他名称:
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有源比较器: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.
其他名称:
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.
其他名称:
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.
其他名称:
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.
其他名称:
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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free survival
大体时间: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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次要结果测量
结果测量 |
大体时间 |
---|---|
Response rate
大体时间:assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Tumor shrinkage rate at 8 week
大体时间: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
大体时间:assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
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R0 liver resection rate
大体时间: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
大体时间:assessed every 8 weeks, up to 4 years
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assessed by investigators
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assessed every 8 weeks, up to 4 years
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Time to treatment-failure
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Yoshihiko Maehara, MD,PhD,FACS、Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- 首席研究员:Naohiro Tomita, MD, PhD、Hyogo College of Medicine, Department of Surgery
- 首席研究员:Ichinosuke Hyodo, MD, PhD、Tsukuba University, Graduate School of Medicine
- 首席研究员:Michiaki Unno, MD, PhD、Tohoku University, Division of Gastroenterological Surgery
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ATOM (其他标识符:Radius Health, Inc.)
- UMIN000010209 (其他标识符:UMIN)
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