JPRN-UMIN000010209已完成2 期
Randomized phase ll study of mFOLFOX6 + bevacizumab or mFOLFOX6+cetuximabin liver only metastasis from KRAS wild type colorectal cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- •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 assesse 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 Full 20 or more years-old aged 80 and below
- •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 >= 10.0x104/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
排除标准
- •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
研究者
相似试验
已完成
2 期
Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus modified OPTIMOX plus bevacizumab for metastatic colorectal cancercolorectal cancerJPRN-UMIN000003477Chiba Cancer Center Hospital80
已完成
3 期
Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancermetastatic colorectal cancerJPRN-UMIN000001396West Japan Oncology Group400
已完成
2 期
Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver MetastasesLiver 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 CancerNCT01836653EPS Corporation122
已完成
2 期
Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal canceradvanced colorectal cancerJPRN-UMIN000002042Tohoku Clinical oncology, reserach and Education Society (T-CORE)65
进行中（未招募）
不适用
Marker Evaluation for Avastin Research in colorectal cancerEUCTR2011-004755-39-EEGenentech, Inc.360