EUCTR2013-002347-28-ES进行中（未招募）不适用
Phase II interventional trial for the assessment of histological responses in all resected colorectal cancer liver metastases after preoperative cetuximab-based chemotherapy. - ERBIMET
ACROSS: Associació Catalana per a la Recerca Oncològica i les seves implicacions sanitàries i Socials0 个研究点开始时间: 2013年7月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Man or woman >= 18 years old
- •2.Able of understand, sign and date an informed consent form aproved by the ethics committee.
- •3.Metastasic colorectal cancer histologically confirmed by the investigator.
- •4.KRAS colorectal cancer (determined in primary tumor) with liver metastases limited to the liver, unresectable or potentially resectable, determined within the Multidisciplinary committee.
- •5.ECOG performance status (Eastern Cooperative Oncology Group)< 2
- •6.Bone marrow funtion properly: neutrophils >=1,5 x 109/L; platelets >= 100 x 109/L; hemoglobin >=9 g/dL.
- •7.Funtions hepatic, renal and metabolic, as follows:
- •or adequate liver function: SAT (SGOT) and ALAT (SGPT) 2.5 x LSN (5 x LSN for liver metastases). Total bilirrubin < 3 x LSN. Alkaline phosphatase 2,5 x LSN ( 5 x LSN in case of liver metastases)
- •or renal function, calculated as creatinine clearance or creatinine clearance during 24 hours >= 50 mL/min.or Magnesium >= LIN, calcium >= LIN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Presence of metastasic colorectal carcinoma with unresectable extrahepatic metastases.
- •2.Patients with a single resectable liver metastases.
- •3.Prior liver resection
- •4.Pre-existing clinically relevant (> grade 1) peripheral sensory neuropathy (e.g. paraesthesia, dysaesthesia).
- •5.The presence of active systemic infection at the time of inclusion in the study.
- •6.Patients who have had a myocardial infarction within the last twelve months before the start of the study or any other clinically rellevant cardiovascular disease.
- •7.Active inflammatory bowel disease or ileus
- •8.Any concurrent disease that may increase the rick of toxicity
- •9.Past or current history of neoplasm, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
- •10.History of any disease that may increase the risks associated with study participation or may interfere with the interpretarion of study results.
- •11.Participation in a clinical trial administration of investigational drugs within 30 days prior to study entry.
- •12.Pregnant or breast-feeding, or planning to become pregnant within 6 months after the end of treatment.
- •13.Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, ie use 2 forms of birth control together, at least 1 of them barrier (eg., condom and control pills) or abstinence during the study and for 6 months after the last administration of study drug for womenn and 1 month for men.
- •14.The subject has a disorder of any kind that compromises their ability to provide written informed consent and / or comply with study procedures.
- •15.The subject is unwilling or unable to meet the requirements of the study.
- •16.The subject is not a candidate for surgery undergo liver metastases, according to the Committee's assessment Multidisciplinary
研究者
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