NCT01836653已完成2 期
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Proteinuria =< 2+ 11.Written informed consent
排除标准
- •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
研究组 & 干预措施
mFOLFOX + Bmab
Experimental
mFOLFOX plus bevacizumab
干预措施: Bevacizumab (Drug)
mFOLFOX + Bmab
Experimental
mFOLFOX plus bevacizumab
干预措施: L-OHP (Drug)
mFOLFOX + Bmab
Experimental
mFOLFOX plus bevacizumab
干预措施: l-LV (Drug)
mFOLFOX + Bmab
Experimental
mFOLFOX plus bevacizumab
干预措施: 5-FU (Drug)
mFOLFOX + Cmab
Active Comparator
mFOLFOX plus cetuximab
干预措施: Cetuximab (Drug)
mFOLFOX + Cmab
Active Comparator
mFOLFOX plus cetuximab
干预措施: L-OHP (Drug)
mFOLFOX + Cmab
Active Comparator
mFOLFOX plus cetuximab
干预措施: l-LV (Drug)
mFOLFOX + Cmab
Active Comparator
mFOLFOX plus cetuximab
干预措施: 5-FU (Drug)
结局指标
主要结局
Progression-free survival
时间窗: assessed every 8 weeks, up to 4 years
assessed by Independent Review Committee
次要结局
- Response rate(assessed every 8 weeks, up to 4 years)
研究者
研究点 (1)
Loading locations...
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