EUCTR2012-000265-20-AT进行中（未招募）1 期
A perioperative, single-arm multicenter Phase II academic trial to investigate the efficacy and safety of panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI) in patients with previously untreated, wild-type RAS, potentially resectable colorectal cancer liver metastases - LM 02
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点目标入组 36 人开始时间: 2012年5月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •- histologically confirmed metastatic colorectal cancer with potentially resectable liver metastases
- •- primary tumor in-situ or resected (in case of resected primary tumor, neoadjuvant short-time radiotherapy is allowed if terminated > 14 days prior to registration)
- •- subjects with wild-type RAS tumor status confirmed by assessment of paraffin embedded tumor tissue from the primary tumor or metastases
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- at least one measurable metastatic lesion in the liver as per RECIST 1.1 guidelines using multislice 3 phase CT
- •- man or woman > 18 years
- •- hematologic function, as follows (< 28 days of registration): absolute neutrophil count (ANC) > 1.5 x 109/L; leucocyte count > 3.0 x 109g/L; platelet count > 100 x 109/L; hemoglobin > 9 x g/dL
- •- renal function, as follows (< 28 days of registration): creatinin < 1.5 x upper limit of normal (ULN)
- •- hepatic function, as follows (< 28 days of registration): aspartate aminotransferase (AST) < 5 x ULN in presence of liver metastases; alanine aminotransferase (ALT) < 5 x ULN in presence of liver metastases; total bilirubin < 1.5 x ULN
- •- women of childbearing potential must have a negative pregnancy test done within 1 week before registration
- •- competent to comprehend, sign, and date an IEC/IRB-approved informed consent form
- •- life expectancy > 3 months
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- prior chemotherapy for the treatment of current metastatic cancer (including biologics)
- •- current extrahepatic metastatic disease
- •- prior chemotherapy and/or resection of any metastases from mCRC <5 years
- •- prior adjuvant or neoadjuvant (chemo-) therapy for the treatment of colorectal cancer = 26 weeks prior to registration
- •- radiotherapy = 14 days prior to registration (patients must have recovered from all radiotherapy-related toxicities)
- •- previous malignancy other than CRC in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •- active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to registration
- •- any investigational agent or therapy < 28 days before registration
- •- clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before registration
- •- known allergy or hypersensitivity to irinotecan, 5-FU, leucovorin or panitumumab
- •- history of severe adverse events to iodinated contrast agents
- •- history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •- known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •- any co-morbid disease or condition that could increase the risk of toxicity
- •- any uncontrolled concurrent illness or history of any medical condition that may interfere with the interpretation of the study results
- •- major surgical procedure (requiring general anaesthesia) < 28 days - patients must have recovered from surgery-related toxicities
- •- subject who is pregnant or breast feeding or planning to become pregnant within 6 months after the end of treatment
- •- woman or man of childbearing potential not consenting to use adequate contraceptive precautions (double barrier contraceptive methods e.g. diaphragm plus condom), or abstinence during the course of the study and 6 months after the last study drug administration
- •- subject unwilling or unable to comply with study requirements
研究者
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