Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03161041
Status:
WITHDRAWN
Last Update Posted:
2018-11-14
First Post:
2017-05-18
Brief Title:
Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis - French Part of the Main Bev-IP Study
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CHU Lyon will join as a participating center and as national French coordinator as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Selected patients with peritoneal carcinomatosis PC from colorectal cancer CRC benefit from cytoreductive surgery CRS combined with intraperitoneal chemoperfusion IPC However even after optimal cytoreduction systemic and locoregional recurrence are common Perioperative chemotherapy with bevacizumab BEV may improve the outcome of these patients The BEV-IP study is a phase II single-arm open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality primary composite endpoint Secondary endpoints are treatment completion rate chemotherapy-related toxicity pathological response progression free survival and overall survival
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None