Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-18 @ 2:24 AM
Study NCT ID:
NCT03085992
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2016-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer
Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Organization:
Study Overview
Official Title:
Open-label Phase II Study of Induction Treatment With Folfoxiri Plus Bevacizumab Followed by Preoperative Chemoradiotherapy Plus Bevacizumab in Patients With Locally Advanced, Resectable Rectal Cancer.
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST
Brief Summary:
This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.
Detailed Description:
None
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 |
|---|---|---|---|---|
| 2011-003340-45 | EUDRACT_NUMBER | None | View |