Preoperative chemoradiation with capecitabine and cetuximab within a multidisciplinary therapeutic approach in patients with operable T3-T4 rectalcancer: a phase II study

ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点目标入组 31 人开始时间: 2005年9月22日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•- Age: 18-80
•- bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
•- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
•- WHO performance status 0-2
•- adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
•- adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
•- adequate renal function (creatinin - not more than 1.5 mg/dl)
•- women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
•- willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-controll pill, loop, condom) during and at least 3 month after conclusion of the study
•- life expectancy of at least 3 month
•- signed Informed Consent before recruitment
•- exclusion of distant metastases at the time of recruitment
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- former radiotherapy of pelvis or abdomen
•- former chemotherapy
•- any other kind of malign tumor in the last 5 years (except adequate treated skin basalioma or in situ cervical carcinoma)
•- general contraindiction or known hypersensitivity against Cetuximab and/or Capecitabine
•- Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitbine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
•- florid, serious infections at the time of recruitment
•- legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
•- evidence of lacking cooperation of the patient
•- pregnant or breast feeding women

发起方

ABCSG (Austrian Breast & Colorectal Cancer Study Group)