NL-OMON39488已完成2 期
Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver metastases form wild type KRAS colorectal cancer. EORTC 40091. - BOS 2
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- 18 至 99（—）
入选标准
- •- Histologically proven CRC with 1 to 8 metachronous or synchronous
- •liver metastases considered to be completely resectable. (Defined in
- •section 5.5).
- •- Primary tumor (or liver metastasis) of CRC must be KRAS status *wild
- •- Patients must have undergone complete resection (R0) of the primary
- •tumor at least 4 weeks before randomization. Or for patients with
- •synchronous metastases the primary tumor can be resected (R0) at the
- •same time as the liver metastases if: the patient has a non-obstructive
- •primary tumor and is able to receive preoperative chemotherapy (3-4
- •months) before surgery.
- •- Measurable hepatic disease by Response Evaluation Criteria in Solid
- •Tumors (RECIST version 1.1).
- •- No evidence of extra-hepatic metastasis (of CRC).
- •- Patients must be 18 years old or older.
- •- A World Health Organization (WHO) performance status of 0 or 1.
- •- No previous chemotherapy for metastatic disease or surgical treatment
- •(e.g. surgical resection or radiofrequency ablation) for liver metastasis.
- •Radiotherapy alone is allowed if given pre or post protocol treatment.
- •- Previous adjuvant chemotherapy for primary CRC is allowed if
- •completed at least 12 months before inclusion in this study.
- •- No major surgical procedure, open biopsy, or significant traumatic
- •injury within 4 weeks prior to randomization.
- •- All the following tests should be done within 4 weeks prior to
- •randomization:
- •- Absolute neutrophil count >= 1.5 x 109/L, platelets >= 100 x 109/L,
- •hemoglobin >= 9 g/dL and white blood cell count (WBC) >= 3 x
- •- Serum creatinine <= 1.5 times the upper limit of normal (ULN) (to
- •exclude severe renal impairment); no significant proteinuria (urine
- •protein < 1g/24 hours urine collection) OR urine protein/creatinine
- •ratio < 1.0 OR 1+ proteinuria on urine dipstick.
- •- Absence of major hepatic insufficiency (bilirubin <= 1.5 x ULN and
- •aspartate aminotransferase (ASAT) and alanine aminotransferase
- •(ALAT) <= 5 x ULN).
- •- Magnesium >= lower limit of normal (LLN)
- •- Patients with a buffer range from the normal values of +/- 5% for
- •hematology and +/- 10% for biochemistry are acceptable. This will
- •not apply for Renal Function, including Creatinine.
- •- No previous exposure to Epidermal Growth Factor Receptor (EGFR) or
- •Vascular Endothelial Growth Factor Receptor (VEGF/VEGFR)
- •targeting therapy within the last 12 months.
- •- No regular use of aspirin or other non-steroidal anti-inflammatory drugs
- •- No bleeding diathesis (e.g. hemoptysis of >= 1/2 teaspoon or 2.5mL),
- •coagulopathy, or need for administration of full-dose anti-coagulant(s).
- •- Absence of peripheral neuropathy > grade 1 (Common Terminology
- •Criteria for Adverse Events, v4.0) serious wound complications, ulcers,
- •or bone fractures.
- •- No clinically significant cardiovascular disease, including: uncontrolled
- •hypertension, New York Heart Association (NYHA) class II-IV heart
- •failure, myocardial infarction or unstable angina pectoris,
- •cerebrovascular accident or transient ischemic attack within the past 12
- 另有 6 项未显示
排除标准
- •not resectable liver metastases
- •extra hepatic disease
研究者
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