Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02941536
Status:
COMPLETED
Last Update Posted:
2018-12-27
First Post:
2016-10-20
Brief Title:
Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-12
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:
None
Brief Summary:
This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic radiotherapy in single or fractionated dose and correlate with the local and distant brain progression-free survival in patients with metastatic breast cancer
Detailed Description:
Brain metastases BM are the most prevalent tumors of the central nervous system CNS with a ratio of 10 1 relative to primary tumors In breast cancer BM are becoming more frequent due to longer life expectancy Patients with HER2-positive metastatic disease are prone to develop BM more often and they occur in 20 - 40 of cases Circulating tumor cells CTC originate from the primary tumor and can migrate to distant organs The possible correlation between CTC and the incidence of brain metastases could help define radiotherapy in patients with oligometastatic or not so widespread disease in the brain However there are few studies that evaluate these scenarios Purpose To assess the number of CTC before and 4-5 weeks after focal stereotactic radiotherapy in single SRS or fractionated SFRT dose and correlate with the local and distant brain progression free survival in patients with metastatic breast cancer Potential invasion markers in these cells will be evaluated and correlated with clinical outcome Patients and Methods Prospective single-center research which will be developed at the Radiation Oncology Department of AC Camargo Cancer Center Patients with diagnosis of metastatic breast cancer to the brain with an indication of focal radiotherapy SRS or SFRT will be recruited The blood will be collected and processed for analysis of CTC by the ISET method Rarecells France The invasion markers HER-2 COX-2 EGFR Notch 1 and ST6GALNAC5 will be analyzed on CTC by immunocytochemistry Expected Results If our hypothesis is proven we may include the analysis and quantification of CTC in clinical practice as early indicator of local or distant recurrence in the brain
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