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

• Conditions: RECTAL CARCINOMA WITH RESECTABLE METASTASES AT DIAGNOSIS; MedDRA version: 9.1Level: LLTClassification code 10055097Term: Rectal cancer metastatic

• Registration Number: EUCTR2007-004053-28-IT
• Lead Sponsor: ISTITUTO ONCOLOGICO VENETO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-13
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified