Open, Randomized, Multicenter Phase II Trial With Cetuximab /5-FU/FA/Irinotecan or Cetuximab/5-FU/FA /Irinotecan/Oxaliplatin in K-ras/B-raf Wild Type Patients or With Irinotecan/Oxaliplatin/5-FU/FA With or Without Bevacizumab in K-ras Mutant Patients as Neoadjuvant Treatment in Patients With Non- Resectable Colorectal Liver Metastases.

Technische Universität Dresden15 个研究点分布在 1 个国家目标入组 91 人开始时间: 2013年3月最近更新: 2019年9月11日

适应症

干预措施

试验速览

阶段: 2 期
发起方: Technische Universität Dresden
入组人数: 91
试验地点: 15
主要终点: Response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to investigate the following schedules for efficacy with regard to response rate in neoadjuvant treatment of patients with non-resectable liver metastases:

Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and
Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.

详细描述

Patients with liver metastases from colorectal and without known extrahepatic metastases will be screened for this study including ras status (b-raf status according to local standard).

Patients receive chemotherapy according to the allocation and are re-evaluated for resectability every 8 weeks for a maximum of 6 months. Resectable patients will be resected and receive an adjuvant treatment to complete 12 cycles.

In certain circumstances, a second resection is allowed within the study.

Patients will be randomized using a web-based computer system that allows randomization if the key basic characteristics are entered.

Patients with ras wild-type tumours will be randomized to receive:

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: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

•Any evidence of extrahepatic metastases, distant lymph node metastases and primary tumour recurrence
•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)
•Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic interventions or venous port implantation) ≤ 4 weeks before study entry
•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
•Hypertension with an arterial blood pressure > 150/90 mmHg
•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)
•Known proteinuria > 1 g/day (to be tested if proteinuria more than 1+ in the urinary dipstick analysis)
•Peripheral neuropathy > CTC grade I
•Concurrent systemic immune therapy, chemotherapy, hormone therapy, or patients receiving immune suppressive treatment (i.e. for transplantation, severe rheumatologic disease)
•Participation in clinical trials with investigational agents within 30 days before start of the treatment in study
•Active treatment of
•peptic ulcers or bleeding erosive esophagitis / gastritis within 3 months before study
•pulmonary embolism, severe or unstable angina pectoris or myocardial infarction, stroke or transient ischemic attack within 12 months before study
•deep vein thrombosis within 4 weeks before study
•Inflammatory bowel disease
•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
•History of brain metastases
•History of severe psychiatric illness
•Active drug- or alcohol abuse
•Known hepatitis B or C or HIV infection
•Breast- feeding or pregnant women
•Lack of effective contraception (for male and female patients)
•Known intolerance to one of the following drugs: cetuximab, bevacizumab, oxaliplatin, irinotecan, 5-FU, folinic acid

研究组 & 干预措施

Cetuximab/FOLFIRI

Active Comparator

Cetuximab 250 mg/m² (1 h) weekly Irinotecan 180 mg/m² (1 h)*, d-l Folinic acid 400 mg/m² (2 h), 5-FU 400 mg/m² (Bolus), 5-FU 2400 mg/m² (46 h) every 2 weeks