Spinal TumorST-SBRTNCT06587022
Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors
An observational study of Spinal Tumor, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- Target volume delineation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Dec 2027
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant tumor spinal metastasis who received or will receive stereotactic radiotherapy, without preoperation.
Who may be able to join
- Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
- Patients with sufficent pre-treatment imaging data
- Patients who can cooperate with imaging review and follow-up after radiotherapy.
Who cannot join
- Patients with an expected survival of less than 3 months;
- Patients with second-course radiotherapy;
- Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
- Patients with extensive spinal metastasis and no local therapeutic value
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
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, 100191
Hongqing Zhuang, 13051776232, hongqingzhuang@163.com
About this study
The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.
Read the detailed description
The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1：The target bolume only includes local tumor. Group 2：The target bolume includes local tumor and adjacent vertebral area.
- Conditions
- Spinal Tumor
- Being tested
- Target volume delineation
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target volume delineationRadiation
Group 1(small target delineation)：The target bolume only includes local tumor. Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Group 1(small target delineation)：The target bolume only includes local tumor. Receives: Radiation: Target volume delineation | |
| group 2 | Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area. Receives: Radiation: Target volume delineation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate（DCR）
Disease Control Rate（DCR），including complete response（CR），partial response(PR) and stable disease(SD ).
Measured: 2 years
Pain relief rate
VAS Score(Visual Analog Scale Score) decreased after treatment
Measured: 3 months
Secondary outcomes (1)
Incidence of side effects
radiation myelitis,radiation esophagitis, etc.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongqing Zhuang, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587022
- Sponsor's protocol ID
- ST-SBRT
- Acronym
- ST-SBRT
- Status last verified
- Aug 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors
- ClinicalTrials.gov ID
- NCT06587022
- Acronym / sponsor ID
- ST-SBRT / ST-SBRT
- Conditions
- Spinal Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.
Detailed description
The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1：The target bolume only includes local tumor. Group 2：The target bolume includes local tumor and adjacent vertebral area.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Radiation: Target volume delineationGroup 1(small target delineation)：The target bolume only includes local tumor. |
| group 2 | – | Radiation: Target volume delineationGroup 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant tumor spinal metastasis who received or will receive stereotactic radiotherapy, without preoperation.
Key inclusion criteria (3 listed)
- Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
- Patients with sufficent pre-treatment imaging data
- Patients who can cooperate with imaging review and follow-up after radiotherapy.
Key exclusion criteria (4 listed)
- Patients with an expected survival of less than 3 months;
- Patients with second-course radiotherapy;
- Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
- Patients with extensive spinal metastasis and no local therapeutic value
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 |
|---|---|---|
| Target volume delineationGroup 1(small target delineation)：The target bolume only includes local tumor. Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area. | Radiation | group 1, group 2 |
Primary outcome
Disease Control Rate（DCR）
Time frame: 2 years
Disease Control Rate（DCR），including complete response（CR），partial response(PR) and stable disease(SD ).
Pain relief rate
Time frame: 3 months
VAS Score(Visual Analog Scale Score) decreased after treatment
1 secondary outcome
Incidence of side effects
Time frame: 2 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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Hongqing Zhuang study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Tumor, run by Peking University Third Hospital 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 3 inclusion and 4 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 19 Sep 2024. 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.
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 Hongqing Zhuang, Doctor (13051776232, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate（DCR） (time frame: 2 years). The study lists 2 primary outcomes in all. 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 19 Sep 2024.