MULTICENTER PHASE II STUDY FOR THE EVALUATION OF BEVACIZUMAB, OXALIPLATIN AND CAPECITABINE IN THE TREATMENT OF ELDERLY PATIENTS WITH ADVANCED COLORECTAL CANCER - BOXE

• Conditions: advanced colorectal cancer; MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019463-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. CARLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1) diagnosis of colorectal cancer; 2) age >= 70 years; 3) measurable lesions; 4) no previous chemotherapy treatment; 5) life expectancy almost of 12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
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

1) Performance Status (ECOG)> 2; 2) >3 comorbidities; 3) previous chemotherapy for advanced disease; 4) brain metastasis; 5) other malignancies.

Study & Design

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