EUCTR2012-005048-46-IT
Active, not recruiting
Not Applicable
First-line FOLFIRI and bevacizumab in patients with advanced colorectal cancer prospectively stratified according to serum LDH - CENTRAL (ColorEctalavastiNTRiALdh)
Fondazione GISCAD0 sitesMay 6, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- patients treated with first-line chemotherapy and bevacizumab will be prospectively stratified according to LDH serum levels
- Sponsor
- Fondazione GISCAD
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •No prior treatment for advanced disease (adjuvant therapy allowed)
- •age \< 75 years \< 18 years
- •Histologically/cytologically confirmed advanced, colorectal cancer
- •At least one lesion measurable with CT or MRI scan
- •Performance Status (ECOG) 0\-1 at study entry)
- •Life expectancy of at least 6 months
- •Neutrophils count \=/\> 1\.5 x 109/L, platelets count \=/\> 100 x 109/L, HGB \=/\> 10 g/dL
- •total bilirubin \< 1\.5 x UNL • SGOT and SGPT \=/\< 2\.5 x UNL (\=/\< 5 x UNL in patients with liver metastases)
- •Creatinine \< 1\.5 x UNL
Exclusion Criteria
- •. CNS metastases
- •Severe cardiovascular disease
- •Uncontrolled infections
- •Radiotherapy within 4 weeks of study entry
- •Any experimental drug administered within 4 weeks of study entry
- •Known hypersensitivity to study drug
- •Known drugs or alcohol abuse
- •Pregnant or lactating women (serum Betahcg test)
- •Other tumours, except in situ melanoma or cervix cancer if radically removed
- •Incapability to sign informed consent
Outcomes
Primary Outcomes
Not specified
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