Bevacizumab + Folfox4 or Xelox2 as first- line treatment in colorectal cancer. Randomized phase II study. - GOIM 2802

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022091-31-IT

Enrollment

132

Registered

2011-06-10

Start date

2011-07-06

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Oncologic patients MedDRA version: 13.1 Level: LLT Classification code 10001167 Term: Adenocarcinoma of colon System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: AVASTIN*INFUS 1FL 400MG 16ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histologically proven diagnosis of colorectal cancer -Mutation Status KRAS -No previous first line chemoterapy treatment - 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

Exclusion criteria

Exclusion criteria: -More than one line of treatment -Presence of brain metastases - Patients with uncontrolled diseases(cardiac disease)

Design outcomes

Primary

Measure	Time frame
Main Objective: To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX-2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment.;Secondary Objective: 1-overall survival 2-Time to progression;Primary end point(s): To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX-2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment.	—

Measure

Time frame

Main Objective: To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX-2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment.;Secondary Objective: 1-overall survival 2-Time to progression;Primary end point(s): To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX-2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment.

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Countries

Italy

Outcome results

None listed

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