An open-label, non-randomized phase I/II trial of neoadjuvant radio-immunochemotherapy withcetuximab and 5-FU for advanced rectal cancer

niversity of Cologne0 个研究点开始时间: 2006年3月30日最近更新: 2013年9月16日

适应症

试验速览

暂无简介。

•Signed written informed consent
•Male or female > 18 years of age
•Histologically proven locally advanced adenocarcinoma of the rectum (T3, T4, any nodal stage) with the
•inferior margin of the tumor being no farther than 16 cm from the anal verge
•Surgical resectability or possible sphincter preservation after neoadjuvant treatment
•ECOG Performance Status < 2
•Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L,
•hemoglobin > 10.0 g/dL
•Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, gamma-GT < 3 x ULN
•Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value
•according to Cockroft-Gault equation)
•If of childbearing potential, willingness to use effective contraceptive method for an adequate period of time.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Prior pelvic radiotherapy
•Prior chemotherapy
•Presence of distant metastases
•Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left
•ventricular ejection fraction (LVEF) below the institutional range of normal
•Other chronic bowel disease (malabsorption, inflammatory bowel disease, acute or subacute intestinal
•Prior exposure to EGFR pathway targeting therapy
•Having participated in another clinical trial or any investigational agent in the preceding 30 days
•Any active dermatological condition > Grade 1
•Known allergic/hypersensitivity reaction to any of the components of the treatment
•Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding
•Known drug abuse/alcohol abuse
•Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the
•skin or pre-invasive carcinoma of the cervix
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to
•complete the study or sign meaningful informed consent

发起方

niversity of Cologne