Trials / Completed
CompletedNCT01900717
Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older. This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified | |
| DRUG | LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2015-05-01
- Completion
- 2016-03-01
- First posted
- 2013-07-16
- Last updated
- 2018-12-27
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01900717. Inclusion in this directory is not an endorsement.