Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer
Primary Purpose
Brain Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Circulating tumor cells evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Cancer focused on measuring Circulating Tumor Cells, Stereotactic Radiosurgery
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.
Exclusion Criteria:
- Patients who received WBRT less than 30 days from the initial CTC dosage.
- Patients who received systemic treatment for less than 7 days of the initial CTC dosage.
- Pregnant patients.
Sites / Locations
- AC Camargo Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Circulating Tumor Cells and Radiotherapy
Arm Description
Circulating tumor cells evaluation 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
Outcomes
Primary Outcome Measures
Brain progression-free survival
Local and Distant brain progression
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT02941536
First Posted
October 20, 2016
Last Updated
December 26, 2018
Sponsor
AC Camargo Cancer Center
Collaborators
International Atomic Energy Agency
1. Study Identification
Unique Protocol Identification Number
NCT02941536
Brief Title
Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer
Official Title
Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AC Camargo Cancer Center
Collaborators
International Atomic Energy Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Breast Cancer
Keywords
Circulating Tumor Cells, Stereotactic Radiosurgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Circulating Tumor Cells and Radiotherapy
Arm Type
Other
Arm Description
Circulating tumor cells evaluation 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Circulating tumor cells evaluation
Intervention Description
Sample collection of circulating tumor cells (CTC) before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose.
Primary Outcome Measure Information:
Title
Brain progression-free survival
Description
Local and Distant brain progression
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.
Exclusion Criteria:
Patients who received WBRT less than 30 days from the initial CTC dosage.
Patients who received systemic treatment for less than 7 days of the initial CTC dosage.
Pregnant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas G Castro, MD, MSc
Organizational Affiliation
AC Camargo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AC Camargo Cancer Center
City
São Paulo
State/Province
SP
ZIP/Postal Code
01509-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
6 months after article publication
IPD Sharing Access Criteria
Correlated Area Investigators with publishing background and a defined objective.
Learn more about this trial
Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer
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