EUCTR2011-003288-31-DE进行中（未招募）1 期
Open, randomized, multicenter phase II trial with cetuximab /5-FU/FA/irinotecan or cetuximab/5-FU/FA /irinotecan/oxaliplatin in ras wild type patients or with irinotecan/oxaliplatin/5-FU/FA with or without bevacizumab in ras mutant patients as neoadjuvant treatment in patients with non- resectable colorectal liver metastases - CELIM2
Technical University Dresden0 个研究点目标入组 0 人开始时间: 2011年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Patients can be enrolled, if all of these conditions apply:
- •1)Non-resectable, histologically confirmed, synchronous or metachronous colorectal liver metastases.
- •2)Non-resectability will be documented by a local multidisciplinary tumour board with participation of a surgeon experienced in liver surgery. Patients can be enrolled if they
- •a)are technically non-resectable (locally determined by a multi-disciplinary team discussion based on remaining functional liver tissue after resection, i.e.
- •i)involvement of both portal veins, all hepatic veins, portal vein of the liver lobe and hepatic veins draining the segments of the other liver lobe, or
- •ii)other reasons for less than 30% remaining functional liver tissue after resection)
- •b)have = 5 liver metastases
- •c)are regarded as non-resectable for other reasons (description necessary)
- •3)Patients with simultaneous liver metastases are eligible,
- •a)if the primary tumour was resected at least 1 month prior to chemotherapy
- •b)all of the following conditions apply:
- •i)the primary tumour is clearly resectable,
- •ii)no radiation therapy is planned,
- •iii)liver resection is planned before resection of the primary or at the same operation as the resection of the primary,
- •iv)no two-stage liver resection is planned, and
- •v)all efforts were made to exclude additional distant metastases.
- •4)WHO PS = 1
- •5)Written informed consent
- •6)Adequate bone marrow function, liver function (neutrophils > 1.5 x 109/l; platelets > 100 x 109/l; haemoglobin > 5.0 mmol/l (8.0 g/dl); bilirubin = ULN or = 1.5 x ULN and not increasing more than 25 % within the last 4 weeks; SGOT and SGPT < 5 x UNL)
- •7)Age = 18 years
- •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 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 256
排除标准
- •1)Any evidence of extrahepatic metastases, distant lymph node metastases and primary tumour recurrence
- •2)(deleted)
- •3)Prior systemic anti-tumour therapy with anti- EGFR-, anti-angiogenetic drugs or with chemotherapy (except adjuvant chemotherapy with an interval of = 6 months or in combination with radiation as radio sensitizer)
- •4)Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic interventions or venous port implantation) = 4 weeks before study entry
- •5)Renal insufficiency with serum creatinine = 1.5 x UNL. If serum creatinine is between 1.0 and 1.5 x UNL, the creatinine clearance according to the Cockroft-Gault formula should be = 60 ml/min
- •6)Hypertension with an arterial blood pressure > 150/90 mmHg
- •7)Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last 12 months, significant arrhythmias)
- •8)Known proteinuria > 1 g/day (to be tested if proteinuria more than 1+ in the urinary dipstick analysis)
- •9)Peripheral neuropathy > CTC grade I
- •10)Concurrent systemic immune therapy, chemotherapy, hormone therapy, or patients receiving immune suppressive treatment (i.e. for transplantation, severe rheumatologic disease)
- •11)Participation in clinical trials with investigational agents within 30 days before start of the treatment in study
- •12)Active treatment of
- •a)peptic ulcers or bleeding erosive esophagitis / gastritis within 3 months before study
- •b)pulmonary embolism, severe or unstable angina pectoris or myocardial infarction, stroke or transient ischemic attack within 12 months before study
- •c)deep vein thrombosis within 4 weeks before study
- •13)Inflammatory bowel disease
- •14)History of other malignancies, from which the patient is not 5 years disease free, with the exception of colorectal cancer, or adequately treated basal cell or squamous cell carcinoma of skin or in-situ cervical cancer within 5 years before study
- •15)History of brain metastases
- •16)History of severe psychiatric illness
- •17)Active drug- or alcohol abuse
- •18)Known hepatitis B or C or HIV infection
- •19)Breast- feeding or pregnant women
- •20)Lack of effective contraception (for male and female patients)
- •21)Known intolerance to one of the following drugs: cetuximab, bevacizumab, oxaliplatin, irinotecan, 5-FU, folinic acid
研究者
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