EUCTR2009-014040-11-DE进行中（未招募）1 期
Multimodality treatment including pre- and postoperative systemic chemotherapy plus cetuximab, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from wild type K-ras colon cancer: A prospective multicenter phase II study. - COMBATAC
niversity of Regensburg0 个研究点目标入组 60 人开始时间: 2010年7月1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
- 入组人数
- 60
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
- •-Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven wt-RAS colorectal or appendiceal adenocarcinoma
- •- Complete macroscopic cytoreduction (CCR-0/1)
- •- 3-12 cycles of systemic chemotherapy (FOPLFOX/FOLFIRI) including cetuximab as preoperative induction therapy
- •- Availability of CT scan prior to preoperative chmeotherapy allowing for sufficient response evaluation
- •- Age over 18 and below 71 years
- •- Good general health status (Karnofsky > 70%, ECOG 0-2)
- •- Absence of hematogenous metastasis (lung, bone, brain, > 3 peripheric resectable liver metastases)
- •- Absence of contraindication for systemic chemotherapy and/or extended surgery
- •- Life expectancy greater than 6 months
- •- Written informed consent
- •- Creatinine clearance > 50 ml/min, serum creatinine = 1.5 x ULN
- •- Serum bilirubin = 1.5 x ULN (upper limit of normal), ASAT and ALAT = 2.5 x ULN
- •- Platelet count > 100,000 /ml, haemoglobin > 9 g/dl, neutrophile granulocytes = 1,500 /ml, International Normalized Ration (INR) = 2
- •- Absence of peripheral neuropathy > grade 1 (CTCAE v4.0)
- •- No pregnancy or breast feeding. Adequate contraception in fertile patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Incomplete cytoreduction, tumordebulking, palliative surgery
- •- Hematogenous metastasis including irresectable liver metastasis
- •- Chemotherapy or therapy with EGFR receptor antibody for metastatic disease prior to actual induction therapy
- •- RAS mutation (exon 2,3 and 4 or KRAS and NRAS) or unknown RAS statuts
- •- Known allergy to murine or chimeric monoclonal antibodies
- •- Histology of signet ring carcinoma (> 20%)
- •- Other malignancy than disease under study / second cancer < 5 years after R0 resection
- •-Impaired liver, renal or hematologic function as mentioned above (inclusion criteria)
- •- Heart failure NYHA = 2 or significant Coronary Artery Disease
- •- Alcohol and/or drug abuse
- •- Patients unable or unwilling to comply with the study protocol, treatment or follow-up
- •- Patients included in other clinical trials interfering with the present study
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