A randomized trial investigating the role of FOLFOX-4 regimen duration (3 versus 6 months) and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer - 3 months vs 6 months FOLFOX-4
- Conditions
- treatment of metastatic colorectal cancerMedDRA version: 9.1Level: LLTClassification code 10061045Term: Colon neoplasm
- Registration Number
- EUCTR2007-000354-31-IT
- Lead Sponsor
- GISCAD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Histologically confirmed AJCC/UICC high-risk stage II or stage III colon cancer .
Age >18 years
Curative surgery no less than 3 and no more than 8 weeks prior to randomization
ECOG performance Status (ECOG-PS) <1
Signed written informed consent obtained prior to any study specific procedures
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
Macroscopic or microscopic evidence of residual tumor
Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer
Other malignancies within the last 5 years
Lactating women
Fertile women not willing to use effective means of contraception
History of clinically relevant psychiatric disability , precluding informed consent
Clinically relevant cardiovascular disease
Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether a 3-month FOLFOX-4 treatment is not inferior to a 6-month FOLFOX-4 treatment in terms of relapse free survival (RFS) in patients with radically resected stage II/III colon cancer;Secondary Objective: To assess whether a 3-month FOLFOX-4 treatment is not inferior to to a 6-month FOLFOX-4 treatment in terms of overall survival (OS) in patients with radically resected stage II/III colon cancer<br>To evaluate the safety profiles of the treatment groups;Primary end point(s): relapse free survival
- Secondary Outcome Measures
Name Time Method