Combined chemio-radioterapy regimen of 5-FU plus irinotecan followed by chemotherapy for the treatment of colorectal cancer with resectable metastases at diagnosis - ND

ISTITUTO ONCOLOGICO VENETO0 个研究点开始时间: 2007年11月13日最近更新: 2012年4月3日

试验速览

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•every age (patients >=70 years old will undergo multidimensional geriatric assessment), histological diagnosis of middle-low rectal carcinoma, measurable synchronous metastases at the diagnosis according to WHO criteria, chemonaive patients, female potential fertile patients and sexually active males only under active contraception during and at least one year after completing treatment, ECOG PS<=2, written informed consent
•Are the trial subjects under 18? yes
•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

•active second malignancy (with exception of skin and in-situ cervical tumors), other malignancies whitin the last 5 years except cured basal cell carcinoma of the skin and carcinoma in-situ of the uterin cervix, ceongestive hearth failure grade 2, myocardial infarction in the last year, unstable angina, uncontrolled hugh risk hypertension or arhythmias, hystory of significant history of significant neurological or psychiatric disorders including dementia or seizures, serious uncontrolled active infections or any other serious uncontrolled concomitant illness, ictus within the last 6 months, interstitial pulmonary disease; peripheral neuropathy >= grade 1, chronic enteric diseases (Crohn disease, ulcerous colitis), unresolved diarrhoea and bowel obstruction; documented cerebral metastasis, anticoagulant therapy or FANS ongoing.

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