Spinal Bone MetastasesSM-SBRTNCT05808998
A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy
An observational study of Spinal Bone Metastases and Radiation Therapy, run by Shanghai Zhongshan Hospital.
Trial summary
A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Bone Metastases, Radiation Therapy
- What is being tested?
- Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 45 patients with spinal metastases were enrolled in this study.
Who may be able to join
- Spinal metastasis diagnosed by emission computed tomography, X-ray examination, computed tomography, magnetic resonance imaging (MRI) or 18F-fluorodeoxy glucose positron emission tomography within 6 weeks before enrollment;
- Patients with unresectable spinal metastases;
- SBRT was for patients with painful spinal metastases, physiological hypofunction, decreased behavioral capacity and quality of life. And SBRT was used to help to prevent or delay skeletal related event (SRE). Including postoperative radiotherapy (especially post-separation), single or salvage radiotherapy;
- age 18-75 years old;
- KPS score equal to 70 points or over;
- Patients were required to have histologically confirmed metastatic disease from solid tumors, such as breast cancer, renal carcinoma or liver cancer;
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- The distance between metastatic lesion and spinal cord was more than 3mm；
- Hemoglobin >90g/L, white cells count≥3.5×109/L, platelet count≥80×109/L, within 1 week before treatment;
- No birth plans for the duration of study participation and up to 3 months following completion of therapy;
- Sign the informed consent.
Who cannot join
- Spinal cord or cauda equina compression, the rapid decrement of neurological function or paralysis;
- A compression fracture of the spine, spinal instability and subsequent inability to lie on back;
- Metastatic lesions more than 5cm;
- Multilevel segments involvement, including more than 5 metastatic segments, or 3 isolated lesions, or exceed two adjacent vertebrae;
- The treatment site had received prior radiotherapy prior to the initiation of the study;
- Complicated with other malignant tumors or severe internal diseases affected the prognosis;
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- Cannot tolerate radiation therapy, including the ones with scleroderma or connective tissue diseases, or cann't complete the radiation treatment according to the research;
- Pregnant women or breast feeding mothers;
- Systemic radionuclide therapy within 30 days before SBRT, or external radiotherapy within 90 days before SBRT;
- Pathologically confirmed as myeloma or lymphoma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Trial of Stereotactic Radiotherapy on Spinal Metastasis
A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.
Read the detailed description
In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
- Conditions
- Spinal Bone Metastases, Radiation Therapy
- Being tested
- Stereotactic body radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Stereotactic body radiotherapy using TomoTherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year local control rate
The proportion of complete remission, partial remission, stable disease, and disease progression patients in the total number of enrolled cases. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
Measured: 2024.4-2025.4
Secondary outcomes (6)
1- and 2- year overall survival (OS)
year overall survival (OS): From day of radiotherapy until the date of death or the end in 1 year, 2-year OS: From day of radiotherapy until the date of death or the end in 2 years
Measured: 2024.4-2026.4
1- and 2-year Progression-Free Survival(PFS)
1-year Progression-Free Survival (PFS)：From day of radiotherapy until the Progression of bone metastases sites in 1 year, 2-year PFS：From day of radiotherapy until the Progression of bone metastases sites in 2 years
Measured: 2024.4-2026.4
Pain relief
Assessment of pain will be according to the Numerical Rating Scale (NRS).
Measured: 2024.4-2026.4
Bone metastasis-related events (SRE)
Bone metastasis-related events will be recorded, including pathological fracture and spinal cord compression, etc.
Measured: 2024.4-2026.4
Epidural spinal cord compression (ESCC) grade
Epidural spinal cord compression (ESCC) grade will be assessed refer to ESCC scale.
Measured: 2024.4-2026.4
Adverse reactions
1-Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 2024.4-2026.4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808998
- Sponsor's protocol ID
- ZS-SM-SBRT
- Acronym
- SM-SBRT
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Stereotactic Radiotherapy on Spinal Metastasis
- ClinicalTrials.gov ID
- NCT05808998
- Acronym / sponsor ID
- SM-SBRT / ZS-SM-SBRT
- Conditions
- Spinal Bone Metastases, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 12 Apr 2023 (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.
A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.
Detailed description
In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 45 patients with spinal metastases were enrolled in this study.
Key inclusion criteria (10 listed)
- Spinal metastasis diagnosed by emission computed tomography, X-ray examination, computed tomography, magnetic resonance imaging (MRI) or 18F-fluorodeoxy glucose positron emission tomography within 6 weeks before enrollment;
- Patients with unresectable spinal metastases;
- SBRT was for patients with painful spinal metastases, physiological hypofunction, decreased behavioral capacity and quality of life. And SBRT was used to help to prevent or delay skeletal related event (SRE). Including postoperative radiotherapy (especially post-separation), single or salvage radiotherapy;
- age 18-75 years old;
- KPS score equal to 70 points or over;
Key exclusion criteria (10 listed)
- Spinal cord or cauda equina compression, the rapid decrement of neurological function or paralysis;
- A compression fracture of the spine, spinal instability and subsequent inability to lie on back;
- Metastatic lesions more than 5cm;
- Multilevel segments involvement, including more than 5 metastatic segments, or 3 isolated lesions, or exceed two adjacent vertebrae;
- The treatment site had received prior radiotherapy prior to the initiation of the study;
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 |
|---|---|---|
| Stereotactic body radiotherapyStereotactic body radiotherapy using TomoTherapy | Radiation | – |
Primary outcome
1-year local control rate
Time frame: 2024.4-2025.4
The proportion of complete remission, partial remission, stable disease, and disease progression patients in the total number of enrolled cases. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
6 secondary outcomes
1- and 2- year overall survival (OS)
Time frame: 2024.4-2026.4
1- and 2-year Progression-Free Survival(PFS)
Time frame: 2024.4-2026.4
Pain relief
Time frame: 2024.4-2026.4
Bone metastasis-related events (SRE)
Time frame: 2024.4-2026.4
Epidural spinal cord compression (ESCC) grade
Time frame: 2024.4-2026.4
Adverse reactions
Time frame: 2024.4-2026.4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Bone Metastases and Radiation Therapy, run by Shanghai Zhongshan Hospital.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, MD (17821701209, zhang.li12@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year local control rate (time frame: 2024.4-2025.4). 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 12 Apr 2023.