Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT01532804
Status:
TERMINATED
Last Update Posted:
2019-12-26
First Post:
2012-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2nd-line Treatment of Metastatic Colorectal Cancer
Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Organization:
Study Overview
Official Title:
A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
too slow recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEVATOMOX
Brief Summary:
This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.
Detailed Description:
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:
* Center
* Number of metastatic sites: 1 versus \> 1
* Bevacizumab-based first-line therapy: Yes versus No
* Center
* Number of metastatic sites: 1 versus \> 1
* Bevacizumab-based first-line therapy: Yes versus No
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-023447-15 | EUDRACT_NUMBER | None | View |