Bevacizumab + Folfox4 or Xelox2 as first- line treatment in colorectal cancer. Randomized phase II study. - GOIM 2802
- Conditions
- Oncologic patientsMedDRA version: 13.1Level: LLTClassification code 10001167Term: Adenocarcinoma of colonSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-022091-31-IT
- Lead Sponsor
- GOIM GRUPPO ONCOLOGICO MERIDIONALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
-More than one line of treatment -Presence of brain metastases -
Patients with uncontrolled diseases(cardiac disease)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method