Bone MetastasesPhase 1/2NCT04947280
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
A Phase 1/2 study testing Fractionated Stereotatic Radiation Therapy in people with Bone Metastases and Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Metastases, Breast Cancer
- What is being tested?
- Fractionated Stereotatic Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of invasive breast cancer
- Signed informed consent
- Bone metastases (confirmed by MRI within 4 weeks of enrollment).
- Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
- KPS ≥ 40 or ECOG 0-2.
- The tumor is at least 2 mm away from the spinal cord. If the tumor is closer than 2 mm, surgical resection is required prior to FSRT or the total prescription dose of spinal cord is strictly limited.
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- Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
- A maximum of three distinct noncontiguous spinal metastases per patient was allowed, and each of the separate sites may have involvement of 2 contiguous vertebral bodies.
- Patients have sufficient bone marrow reserve and liver and kidney function: neutrophil count ≥ 1500 cells / mm3; platelet count ≥ 70000 / mm3; hemoglobin (Hgb) ≥ 8.0 g / dl; if there is liver metastasis, AST and ALT < 3x ULN
- The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment ≤ grade 1
- Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included
Who cannot join
- Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with > 50% loss of vertebral body height were excluded.
- Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
- Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
- Patients who had a history of previous radiotherapy to the spine at the current level of interest.
- Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
- Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.
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- Patients who had received chemotherapy within 2 weeks of starting protocol treatment.
- Patients who are unwilling or unable to receive regular follow-up.
- The patients judged by the researchers who could not be included in some special cases.
- Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Read the detailed description
Eligible breast cancer patients with bone metastases will be treated with FSRT. 9-10 Gy x 3Fx or 6-7 Gy x 5Fx image-guided fractionated stereotatic radiation therapy will be used.
- Conditions
- Bone Metastases, Breast Cancer
- Being tested
- Fractionated Stereotatic Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Stereotatic Radiation TherapyRadiation
Also called Stereotatic Fractionated Radiation
Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Stereotatic Radiation Therapy | Experimental | Not described Receives: Radiation: Fractionated Stereotatic Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate
Determine the local control rate of FSRT in patients with bone metastasis of breast cancer
Measured: 3 years
Secondary outcomes (5)
Pain Control
Evaluate whether FSRT improves pain control as measured by Brief Pain Inventory (BPI) after FSRT in patients with spinal metastasis of breast cancer
Measured: 3 years
Overall Survival
Time from the date of informed consent until to the date of death, regardless of the cause of death
Measured: 3 years
Progression Free Survival
Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first
Measured: 3 years
Quality of Life
Evaluate the quality of life according to EORTC QLQ-BM22
Measured: 3 years
Vertebral Fracture and Radiation Myelitis
Determine the incidence of bone fracture and radiation myelitis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaozhi Yang, MD, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947280
- Sponsor's protocol ID
- FDRT-BC012
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
- ClinicalTrials.gov ID
- NCT04947280
- Acronym / sponsor ID
- FDRT-BC012
- Conditions
- Bone Metastases, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2021 (actual)
- 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.
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Detailed description
Eligible breast cancer patients with bone metastases will be treated with FSRT. 9-10 Gy x 3Fx or 6-7 Gy x 5Fx image-guided fractionated stereotatic radiation therapy will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractionated Stereotatic Radiation Therapy | Experimental | Radiation: Fractionated Stereotatic Radiation Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of invasive breast cancer
- Signed informed consent
- Bone metastases (confirmed by MRI within 4 weeks of enrollment).
- Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
- KPS ≥ 40 or ECOG 0-2.
Key exclusion criteria (11 listed)
- Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with > 50% loss of vertebral body height were excluded.
- Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
- Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
- Patients who had a history of previous radiotherapy to the spine at the current level of interest.
- Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
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 |
|---|---|---|
| Fractionated Stereotatic Radiation TherapyAlso: Stereotatic Fractionated RadiationParticipants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy. | Radiation | Fractionated Stereotatic Radiation Therapy |
Primary outcome
Local Control Rate
Time frame: 3 years
Determine the local control rate of FSRT in patients with bone metastasis of breast cancer
5 secondary outcomes
Pain Control
Time frame: 3 years
Overall Survival
Time frame: 3 years
Progression Free Survival
Time frame: 3 years
Quality of Life
Time frame: 3 years
Vertebral Fracture and Radiation Myelitis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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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.
Zhaozhi Yang, MD, Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fractionated Stereotatic Radiation Therapy in people with Bone Metastases and Breast Cancer, run by Fudan University at 1 site in China.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 1 Jul 2021. 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaozhi Yang, MD, Ph.D (8618017317126, yzzhi2006@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control Rate (time frame: 3 years). 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 1 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.