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: 2018年8月20日

适应症

试验速览

暂无简介。

•-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

•- 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

发起方

niversity of Regensburg