SBRT for Breast Cancer Oligometastases
Primary Purpose
Breast Neoplasm Malignant Female
Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm Malignant Female focused on measuring Stereotactic Body Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Women >18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included.
- Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases.
- Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT.
- Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be >5 cm away from each other (defined as Edge to Edge of tumor).
Exclusion Criteria:
- Non bone metastatic breast cancers
- Prior history of radiotherapy to same sites of SBRT
- Pathologic fractures of involved bones
- Contraindications to radiotherapy including pregnancy and connective tissue disease.
- Patients with impaired cognitive functions.
Sites / Locations
- King Hussein Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stereotactic Body Radiotherapy for Breast Bony oligometastases
Arm Description
Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
the interval from diagnosis until disease progression
Overall survival (OS)
time from diagnosis to death from any cause or last follow-up
Secondary Outcome Measures
Existing metastasis control
the interval from diagnosis until local progression of the treated metastases
Appearance of new metastases
the interval from diagnosis until appearance of new metastases
Adverse Events
CTCAE v5. for acute and chronic toxicity reporting and scoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424732
Brief Title
SBRT for Breast Cancer Oligometastases
Official Title
Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Hussein Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Malignant Female
Keywords
Stereotactic Body Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Body Radiotherapy for Breast Bony oligometastases
Arm Type
Other
Arm Description
Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
the interval from diagnosis until disease progression
Time Frame
5 years
Title
Overall survival (OS)
Description
time from diagnosis to death from any cause or last follow-up
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Existing metastasis control
Description
the interval from diagnosis until local progression of the treated metastases
Time Frame
3 years
Title
Appearance of new metastases
Description
the interval from diagnosis until appearance of new metastases
Time Frame
3 years
Title
Adverse Events
Description
CTCAE v5. for acute and chronic toxicity reporting and scoring
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women >18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included.
Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases.
Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT.
Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be >5 cm away from each other (defined as Edge to Edge of tumor).
Exclusion Criteria:
Non bone metastatic breast cancers
Prior history of radiotherapy to same sites of SBRT
Pathologic fractures of involved bones
Contraindications to radiotherapy including pregnancy and connective tissue disease.
Patients with impaired cognitive functions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulmajeed H Dayyat, MD
Phone
0096265300460
Ext
1860
Email
adayyat@khcc.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulmajeed Dayyat, MD
Organizational Affiliation
King Hussein Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Hussein Cancer Center
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farah Zahran
Phone
0096265300460
Ext
1346
Email
FZahran@KHCC.JO
12. IPD Sharing Statement
Learn more about this trial
SBRT for Breast Cancer Oligometastases
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