Brain CancerNCT02941536
Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer
A study testing Circulating tumor cells evaluation in people with Brain Cancer and Breast Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Brain Cancer, Breast Cancer
- What is being tested?
- Circulating tumor cells evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2016to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer
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.
Read the 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.
- Conditions
- Brain Cancer, Breast Cancer
- Being tested
- Circulating tumor cells evaluation
- Keywords
- Circulating Tumor Cells, Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cells evaluationDiagnostic test
Sample collection of circulating tumor cells (CTC) before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose.
| Study group | Role | What they receive |
|---|---|---|
| Circulating Tumor Cells and Radiotherapy | Other | 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 Receives: Diagnostic Test: Circulating tumor cells evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain progression-free survival
Local and Distant brain progression
Measured: 6 months
Secondary outcomes (1)
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completion15 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Douglas G Castro, MD, MSc, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941536
- Sponsor's protocol ID
- 2258/16
- Status last verified
- Dec 2018
- First submitted
- 20 Oct 2016
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Stereotactic Radiotherapy for Encephalic Metastases of Breast Cancer
- ClinicalTrials.gov ID
- NCT02941536
- Acronym / sponsor ID
- 2258/16
- Conditions
- Brain Cancer, Breast Cancer
- Keywords
- Circulating Tumor Cells, Stereotactic Radiosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulating Tumor Cells and Radiotherapy | Other | Diagnostic Test: Circulating tumor cells evaluationCirculating 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor cells evaluationSample collection of circulating tumor cells (CTC) before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose. | Diagnostic test | Circulating Tumor Cells and Radiotherapy |
Primary outcome
Brain progression-free survival
Time frame: 6 months
Local and Distant brain progression
1 secondary outcome
Overall survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas G Castro, MD, MSc principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating tumor cells evaluation in people with Brain Cancer and Breast Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.