Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02254941
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2014-09-23
Brief Title:
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Sponsor:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Organization:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study Overview
Official Title:
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to evaluate in terms of overall survival the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone Initially expected target population was 1950 patients pts in 2015 protocol was ammended to 1028 patients because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use with HR of 08 power of 90 and an alpha of 005 Finally in July 2018 recruitment was completed with a total of 1104 patients enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None