Spinal MetastasesNCT07801274
Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases
An observational study of Spinal Metastases and Metastatic Epidural Spinal Cord Compression, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Metastases, Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Sep 2028
- How long will I take part?
- 24 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with spinal metastases from solid tumors who underwent surgery and had residual metastatic epidural spinal cord compression (MESCC) requiring postoperative radiotherapy. All participants were enrolled at Tianjin Medical University Cancer Institute and Hospital.
Who may be able to join
- Age 18 to 80 years, any sex.
- Karnofsky Performance Status (KPS) >= 60 or ECOG Performance Status <= 2.
- Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT).
- Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy.
- Number of lesions <= 5, and maximum diameter of a single lesion <= 5 cm.
- Interval between surgery and radiotherapy <= 4 weeks.
- Signed informed consent and willingness to participate in the study.
Who cannot join
- Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease).
- Concurrent brain metastases or other active malignancies.
- Pathological fracture or severe spinal instability requiring emergency surgical intervention.
- Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax >= 45 Gy).
- Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders).
- Severe postoperative complications (e.g., infection, poor wound healing) requiring delayed radiotherapy.
- Incomplete or unreliable medical records from external hospitals.
- Pregnant or lactating 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
300060
Tianjin, Tianjin Municipality
Xu Liming, MD, 86-22-23340123 ext. 1131, xuliming@tjmuch.com
About this study
Official title: Prognostic Study of Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases From Solid Tumors
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.
Read the detailed description
This is a single-center, prospective, observational cohort study conducted at Tianjin Medical University Cancer Institute and Hospital to evaluate the clinical outcomes of postoperative Edge (RapidArc) Stereotactic Body Radiotherapy (SBRT) in patients with spinal metastases from solid tumors. A total of 50 patients with postoperative metastatic epidural spinal cord compression (MESCC) will be enrolled. The treatment protocol prescribes a total dose of 35 Gy in 5 fractions (7 Gy per fraction) delivered using the Edge system. The Edge system features sub-millimeter precision, six-dimensional dynamic positioning, and optical surface monitoring (OSMS), which allows for a steep dose gradient, high biological effective dose (BED), and maximal spinal cord protection. The study will evaluate local control rate (LC) and neurological improvement (Frankel score) at 3 months as the primary outcome. Secondary outcomes include 1-year and 2-year LC, neurological deterioration-free survival (NDFS), overall survival (OS), and quality of life (EORTC QLQ-C30). Adverse events including acute radiation myelitis and esophagitis will be monitored. Data will be analyzed using SPSS 27.0 and R 4.3.2, with survival curves generated via the Kaplan-Meier method and Cox regression models used for prognostic factor analysis.
- Being tested
- Stereotactic Body Radiotherapy
- Keywords
- Stereotactic Body Radiotherapy, Edge System, Postoperative Radiotherapy, Hypofractionated Radiotherapy, MESCC, Observational Study
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
Also called Edge System
Postoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).
| Study group | Role | What they receive |
|---|---|---|
| Edge SBRT Group | Participants received postoperative stereotactic body radiotherapy (SBRT) using the Edge system, prescribed as 35 Gy in 5 fractions (7 Gy per fraction). Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate (LC)
Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
Measured: 3 months post-treatment
Secondary outcomes (4)
Neurological Deterioration-Free Survival (NDFS)
Time from treatment initiation to neurological deterioration or death.
Measured: 1 year and 2 years
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: 1 year and 2 years
Quality of Life (QoL)
Change in quality of life scores assessed by the EORTC QLQ-C30 questionnaire.
Measured: Baseline, 3 months, 1 year, and 2 years post-treatment
Incidence of Adverse Events
Incidence of acute radiation myelitis, esophagitis, vertebral fractures, and skin reactions, graded according to CTCAE v5.0.
Measured: Up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 50 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Liming, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801274
- Sponsor's protocol ID
- E20251145
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect patient confidentiality and adhere to institutional data protection policies.
Publications
Guckenberger M, Andratschke N, Belka C, Bellut D, Cuccia F, Dahele M, Guninski RS, Josipovic M, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel W, Alongi F. ESTRO clinical practice guideline: Stereotactic body radiotherapy for spine metastases. Radiother Oncol. 2024 Jan;190:109966. doi: 10.1016/j.radonc.2023.109966. Epub 2023 Nov 2.
PubMed 37925107
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT07801274
- Acronym / sponsor ID
- E20251145
- Keywords
- Stereotactic Body Radiotherapy, Edge System, Postoperative Radiotherapy, Hypofractionated Radiotherapy, MESCC, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Sep 2026 (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.
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.
Detailed description
This is a single-center, prospective, observational cohort study conducted at Tianjin Medical University Cancer Institute and Hospital to evaluate the clinical outcomes of postoperative Edge (RapidArc) Stereotactic Body Radiotherapy (SBRT) in patients with spinal metastases from solid tumors. A total of 50 patients with postoperative metastatic epidural spinal cord compression (MESCC) will be enrolled. The treatment protocol prescribes a total dose of 35 Gy in 5 fractions (7 Gy per fraction) delivered using the Edge system. The Edge system features sub-millimeter precision, six-dimensional dynamic positioning, and optical surface monitoring (OSMS), which allows for a steep dose gradient, high biological effective dose (BED), and maximal spinal cord protection. The study will evaluate local control rate (LC) and neurological improvement (Frankel score) at 3 months as the primary outcome. Secondary outcomes include 1-year and 2-year LC, neurological deterioration-free survival (NDFS), overall survival (OS), and quality of life (EORTC QLQ-C30). Adverse events including acute radiation myelitis and esophagitis will be monitored. Data will be analyzed using SPSS 27.0 and R 4.3.2, with survival curves generated via the Kaplan-Meier method and Cox regression models used for prognostic factor analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edge SBRT Group | – | Radiation: Stereotactic Body RadiotherapyParticipants received postoperative stereotactic body radiotherapy (SBRT) using the Edge system, prescribed as 35 Gy in 5 fractions (7 Gy per fraction). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with spinal metastases from solid tumors who underwent surgery and had residual metastatic epidural spinal cord compression (MESCC) requiring postoperative radiotherapy. All participants were enrolled at Tianjin Medical University Cancer Institute and Hospital.
Key inclusion criteria (7 listed)
- Age 18 to 80 years, any sex.
- Karnofsky Performance Status (KPS) >= 60 or ECOG Performance Status <= 2.
- Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT).
- Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy.
- Number of lesions <= 5, and maximum diameter of a single lesion <= 5 cm.
Key exclusion criteria (8 listed)
- Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease).
- Concurrent brain metastases or other active malignancies.
- Pathological fracture or severe spinal instability requiring emergency surgical intervention.
- Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax >= 45 Gy).
- Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders).
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 RadiotherapyAlso: Edge SystemPostoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction). | Radiation | Edge SBRT Group |
Primary outcome
Local Control Rate (LC)
Time frame: 3 months post-treatment
Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
4 secondary outcomes
Neurological Deterioration-Free Survival (NDFS)
Time frame: 1 year and 2 years
Overall Survival (OS)
Time frame: 1 year and 2 years
Quality of Life (QoL)
Time frame: Baseline, 3 months, 1 year, and 2 years post-treatment
Incidence of Adverse Events
Time frame: Up to 2 years post-treatment
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 3 Sep 2026.
- Background: PubMed 37925107Guckenberger M, Andratschke N, Belka C, Bellut D, Cuccia F, Dahele M, Guninski RS, Josipovic M, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel W, Alongi F. ESTRO clinical practice guideline: Stereotactic body radiotherapy for spine metastases. Radiother Oncol. 2024 Jan;190:109966. doi: 10.1016/j.radonc.2023.109966. Epub 2023 Nov 2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect patient confidentiality and adhere to institutional data protection policies.
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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.
Xu Liming, MD principal investigator
Tianjin Medical University Cancer Institute and 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 Metastases and Metastatic Epidural Spinal Cord Compression, run by Tianjin Medical University Cancer Institute and 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 7 inclusion and 8 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 3 Sep 2026. 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 Xu Liming, MD (86-22-23340123 ext. 1131, xuliming@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control Rate (LC) (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801274, which also lists 1 linked publication.
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 3 Sep 2026.