Xelox-2 in untreated patients with advanced colorectal cancer.A Phase II multicenter study of the gruppo oncologico dell Italia meridionale GOIM - Xelox-2 in treatment of the colorectal cancer

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2007年7月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•3.1.2 Histologically confirmed adenocarcinoma 33.1.4 Presence of at least one measurable lesion 3.1.5 Age 8805; 18 years and 75 years 3.1.6 Karnofsky performance status of 70 at study entry 3.1.7 Life expectancy of 3 months 3.1.8 Laboratory data Neutrophils 8805; 1.5 x 109/L, platelets 8805; 100 x 109/L, hemoglobin 8805; 9 g/dl ALAT and ASAT 8804; 2.5 x ULN 5 x ULN if liver metastases are present Total Bilirubin 8804; 1.5 x ULN Serum creatinine 8804; 1.5 x ULN 3.1.9 Effective contraception in female patients at risk of conception/absence of pregnancy or breastfeeding 3.1.10 Signed written informed consent.
•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

•3.2.1 Brain metastasis 3.2.2 Previous chemotherapy for locally advanced or metastatic colorectal adjuvant therapy without oxaliplatin is allowed if recurrence is documented 6 months after the end of adjuvant treatment 3.2.5 Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months 3.2.6 Acute or subacute intestinal occlusion or history of the inflammatory bowel disease 3.2.7 Patients with peripheral neuropathy NCI CTC 1 3.2.8 Known grade 3 or 4 allergic reaction to any of the components of the treatment 3.2.9 Known drug abuse/alcohol 3.2.10 Legal incapacity or limited legal capacity 3.2.11 Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent 3.2.12 Women who are pregnant or breastfeeding

发起方

GOIM GRUPPO ONCOLOGICO MERIDIONALE