Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 1:52 PM
Study NCT ID:
NCT01554059
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2012-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients
Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Organization:
Study Overview
Official Title:
Phase II Trial of Neoadjuvant Chemoradiation With Bevacizumab for Chinese Locally Advanced Rectal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2014-11
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:
New Beat
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.
Detailed Description:
Primary endpoint: Pathological Complete Response Rate (pCR)
Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data
Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data
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?: