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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019463-10-IT

Enrollment

Registered

2010-05-10

Start date

2010-12-06

Completion date

Unknown

Last updated

2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced colorectal cancer MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: XELODA Pharmaceutical Form: Tablet INN or Proposed INN: Capecitabine Concentration unit: mg/m2 milligram(s)/square meter Concentration number: 2- Trade Name: OXALIPLATINO RAT Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: activity and toxicity of the proposed combination.;Secondary Objective: treatment effects on quality of life; prognostic evaluation of comorbities; chemotherapy effects on patients'ability during chemotherapy.;Primary end point(s): activity and toxicity of the proposed combination.	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026