Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01827956
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2012-11-05
Brief Title:
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours
Status:
COMPLETED
Status Verified Date:
2013-04
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:
FCRVADS
Brief Summary:
Hypothesis
Cetuximab an anti-EGFR antibody is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers Actually no predictive biomarkers of Cetuximab antitumor activity are known in this setting It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab
The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment
Cetuximab an anti-EGFR antibody is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers Actually no predictive biomarkers of Cetuximab antitumor activity are known in this setting It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab
The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment
Detailed Description:
Hypothesis
Cetuximab an anti-EGFR antibody is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers Actually no predictive biomarkers of Cetuximab antitumor activity are known in this setting It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab
We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment
This study is a multicentre prospective pharmacogenetic observational study conducted on locally advanced and inoperable upper aerodigestive tract cancers
Cetuximab an anti-EGFR antibody is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers Actually no predictive biomarkers of Cetuximab antitumor activity are known in this setting It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab
We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment
This study is a multicentre prospective pharmacogenetic observational study conducted on locally advanced and inoperable upper aerodigestive tract cancers
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