此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)

2017年8月1日 更新者:EPS Corporation

Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.

研究概览

详细说明

Description: The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.

研究类型

介入性

注册 (实际的)

122

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tokyo
      • Shinjuku-ku、Tokyo、日本、162-0814
        • EPS Corporation

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
  2. RAS wild type
  3. 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
  4. 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.

  1. Neu >= 1500/mm3
  2. Pt >= 10.0x10^4/mm3
  3. Hb >= 9.0 g/dL
  4. T-bil =< 2.0 mg/dL
  5. AST and ALT =< 200 IU/L
  6. sCr =< 1.20 mg/dL
  7. INR < 1.5
  8. Proteinuria =< 2+ 11.Written informed consent

Exclusion Criteria:

  1. Previously experienced severe allergic reaction to drugs
  2. Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
  3. Receiving chronic systemic corticosteroid treatment
  4. 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.
  5. Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
  6. Diagnosed as hereditary colorectal cancer
  7. Active other malignancies
  8. Cerebrovascular disease or symptoms less than 1 year prior to entry
  9. Pleural effusion, ascites or cardiac effusion requiring drainage
  10. Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
  11. Perforation of gastrointestinal tract less than 1 year prior to entry
  12. Presence of active infection
  13. HBs antigen or HCV antibody positive
  14. Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
  15. Presence of >= grade 2 diarrhea
  16. Presence of >= grade 1 peripheral neuropathy
  17. Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
  18. Psychosis or psychiatric symptoms who are not able to comply with the protocol
  19. Any other medical conditions disable to comply with the protocol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:mFOLFOX + Bmab
mFOLFOX plus bevacizumab
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:
  • 阿瓦斯汀
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:
  • 奥沙利铂
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:
  • 左亚叶酸
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:
  • 氟尿嘧啶
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:
  • 氟尿嘧啶
有源比较器:mFOLFOX + Cmab
mFOLFOX plus cetuximab
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:
  • 奥沙利铂
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:
  • 左亚叶酸
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:
  • 氟尿嘧啶
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:
  • 氟尿嘧啶
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:
  • 爱必妥

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
assessed by Independent Review Committee
assessed every 8 weeks, up to 4 years

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
assessed every 8 weeks, up to 4 years

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
assessed at 8 week, up to 8 weeks
Liver resection rate
大体时间:assessed every 8 weeks, up to 4 years
assessed every 8 weeks, up to 4 years
R0 liver resection rate
大体时间:assessed every 8 weeks, up to 4 years
pathologically confirmed R0 liver resection rate
assessed every 8 weeks, up to 4 years
Progression-free survival
大体时间:assessed every 8 weeks, up to 4 years
assessed by investigators
assessed every 8 weeks, up to 4 years
Time to treatment-failure
大体时间:assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Overall survival
大体时间:assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Quality of life
大体时间:assessed every 16 weeks, up to 1 year
assessed every 16 weeks, up to 1 year
Incidence of adverse events
大体时间:assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Progression-free survival among the RAS wild type subpopulation
大体时间:assessed every 8 weeks, up to 4 years
All the assessment is repeated for a maximum of 4 years.
assessed every 8 weeks, up to 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年5月1日

初级完成 (实际的)

2017年3月1日

研究完成 (实际的)

2017年3月1日

研究注册日期

首次提交

2013年4月14日

首先提交符合 QC 标准的

2013年4月19日

首次发布 (估计)

2013年4月22日

研究记录更新

最后更新发布 (实际的)

2017年8月2日

上次提交的符合 QC 标准的更新

2017年8月1日

最后验证

2017年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Bevacizumab的临床试验

3
订阅