Spinal NeoplasmsPhase 2NCT07039968
Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms
A Phase 2 study testing Spine Stereotactic Radiosurgery (SSRS) in people with Spinal Neoplasms, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Neoplasms
- What is being tested?
- Spine Stereotactic Radiosurgery (SSRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jun 2025to Jun 2035
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60%.
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- Life expectancy ≥ 12 months.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Who cannot join
- Prior radiotherapy or radiosurgery to the index spine(s)
- Serum creatinine > 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
- Inability to tolerate treatment procedure
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
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- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled psychiatric disorder
- Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Feng-Ming Hsu, M.D., Ph.D, 886-2-23123456 ext. 62643, hsufengming@ntuh.gov.tw
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Feng-Ming Hsu, M.D., Ph.D, 886-2-23123456 ext. 62643, hsufengming@ntuh.gov.tw
About this study
Official title: Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial
The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose.
The main questions it aims to answer are:
Read more
Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life?
Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes:
The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy.
Participants in this study will:
Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor.
Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI).
Complete questionnaires about their pain levels and quality of life during these visits.
Read the detailed description
Study Rationale and Background:
Metastatic cancer to the spine is a significant clinical challenge that can lead to severe pain, neurological compromise, and a diminished quality of life. Stereotactic Spine Radiosurgery (SSRS), also known as Stereotactic Ablative Radiotherapy (SABR), has emerged as a paradigm-shifting treatment. This advanced, non-invasive technique allows for the delivery of a single, highly ablative dose of radiation with unprecedented precision, which has shown excellent rates of pain control and tumor response while minimizing dose to the adjacent, critical spinal cord.
Despite the widespread adoption and promising results of SSRS, the optimal dose-fractionation schedule remains an area of active investigation. Previous research, including the landmark RTOG 0631 trial, has established single-fraction 16 Gy as an effective regimen. However, other evidence suggests that a higher radiation dose may lead to more durable local tumor control. This prospective, randomized phase II study, known as the SHINE trial, is designed to formally compare the efficacy and safety of a higher single-fraction dose against the current standard dose.
Study Design and Procedures:
This is a two-arm, parallel-group, randomized, open-label, multi-center study. After providing informed consent and confirming eligibility, participants will be randomly assigned on a 1:1 basis to receive either the standard dose or the high dose of SSRS. The randomization process will incorporate a minimization procedure to ensure balance between the two arms for the key prognostic factor of epidural or paraspinal tumor extension.
The core intervention for all participants is a single session of SSRS. The treatment will be meticulously planned using fused CT and MRI scans to accurately delineate the tumor (Gross Tumor Volume, GTV) and the area at potential microscopic risk (Clinical Target Volume, CTV), following international consensus guidelines from the International Spine Radiosurgery Consortium (ISRC). Radiation will be delivered using state-of-the-art techniques (IMRT or VMAT/RapidArc) with rigorous on-board image guidance to ensure accuracy. Strict dose constraints will be applied to protect the spinal cord and other nearby organs at risk.
Follow-up and Data Collection:
Following treatment, all participants will enter a comprehensive follow-up phase lasting up to two years. The schedule includes regular clinical evaluations, neurological assessments, and serial imaging (MRI and/or CT) to monitor treatment response and detect any potential late toxicities. Additionally, participants will complete validated questionnaires to assess changes in pain and health-related quality of life. Blood samples will be collected at baseline for correlative science studies to investigate potential genetic biomarkers (such as DDR2) and circulating factors that may predict treatment response or risk of skeletal side effects. This robust data collection will allow for a thorough comparison of the two treatment regimens.
- Conditions
- Spinal Neoplasms
- Being tested
- Spine Stereotactic Radiosurgery (SSRS)
- Keywords
- spine metastasis, stereotactic spine radiosurgery
- Medical subject headings
- Spinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine Stereotactic Radiosurgery (SSRS)Radiation
A non-invasive procedure that uses highly focused, high-energy radiation beams to precisely target metastatic tumors in the spine. The procedure is delivered using advanced techniques like Intensity Modulated Radiotherapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT/RapidArc), which allow the radiation dose to conform tightly to the shape of the tumor. This approach maximizes the dose to the cancer while carefully sparing surrounding healthy tissues, especially the critical spinal cord. The entire course of treatment is delivered in a single session, guided by on-board imaging to ensure sub-millimeter accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose Spine Stereotactic Radiosurgery | Active comparator | Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a dose of 16 Gray (Gy) in a single treatment session. Receives: Radiation: Spine Stereotactic Radiosurgery (SSRS) |
| High Dose Spine Stereotactic Radiosurgery | Experimental | Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a higher dose of 20 Gray (Gy) in a single treatment session. Receives: Radiation: Spine Stereotactic Radiosurgery (SSRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Composite Treatment Failure at 12 Months
This is a composite endpoint that measures the percentage of participants in each arm who experience a treatment failure. A treatment failure is defined as the first occurrence of either of the following events:
Clinically Significant Toxicity: The occurrence of a Grade 3 or higher adverse event that is definitely, probably, or possibly related to the radiation treatment. This includes specific neurological, musculoskeletal (e.g., spinal fracture), or gastrointestinal events as defined in the protocol.
Local Tumor Progression: Unequivocal evidence of tumor growth at the treated spinal site, which is significant enough to warrant further medical intervention, such as spinal surgery or re-irradiation.
Measured: At 12 months after the single fraction of Spine Stereotactic Radiosurgery (SSRS).
Secondary outcomes (1)
Health-Related Quality of Life (EORTC QLQ-C15-PAL)
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL), Taiwan version. This is a 15-item self-reported questionnaire assessing function and symptoms. Scores are converted to a 0-100 scale, with higher functional scores and lower symptom scores indicating better outcomes.
Measured: Baseline, and at 1, 3, 6, 9, and 12 months post-treatment, and then every 3 months for a total follow-up period of up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039968
- Sponsor's protocol ID
- 202503019RINA
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07039968
- Acronym / sponsor ID
- 202503019RINA
- Conditions
- Spinal Neoplasms
- Keywords
- spine metastasis, stereotactic spine radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2035 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 26 Jun 2025 (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 goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose.
The main questions it aims to answer are:
Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life?
Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes:
The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy.
Participants in this study will:
Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor.
Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI).
Complete questionnaires about their pain levels and quality of life during these visits.
Detailed description
Study Rationale and Background:
Metastatic cancer to the spine is a significant clinical challenge that can lead to severe pain, neurological compromise, and a diminished quality of life. Stereotactic Spine Radiosurgery (SSRS), also known as Stereotactic Ablative Radiotherapy (SABR), has emerged as a paradigm-shifting treatment. This advanced, non-invasive technique allows for the delivery of a single, highly ablative dose of radiation with unprecedented precision, which has shown excellent rates of pain control and tumor response while minimizing dose to the adjacent, critical spinal cord.
Despite the widespread adoption and promising results of SSRS, the optimal dose-fractionation schedule remains an area of active investigation. Previous research, including the landmark RTOG 0631 trial, has established single-fraction 16 Gy as an effective regimen. However, other evidence suggests that a higher radiation dose may lead to more durable local tumor control. This prospective, randomized phase II study, known as the SHINE trial, is designed to formally compare the efficacy and safety of a higher single-fraction dose against the current standard dose.
Study Design and Procedures:
This is a two-arm, parallel-group, randomized, open-label, multi-center study. After providing informed consent and confirming eligibility, participants will be randomly assigned on a 1:1 basis to receive either the standard dose or the high dose of SSRS. The randomization process will incorporate a minimization procedure to ensure balance between the two arms for the key prognostic factor of epidural or paraspinal tumor extension.
The core intervention for all participants is a single session of SSRS. The treatment will be meticulously planned using fused CT and MRI scans to accurately delineate the tumor (Gross Tumor Volume, GTV) and the area at potential microscopic risk (Clinical Target Volume, CTV), following international consensus guidelines from the International Spine Radiosurgery Consortium (ISRC). Radiation will be delivered using state-of-the-art techniques (IMRT or VMAT/RapidArc) with rigorous on-board image guidance to ensure accuracy. Strict dose constraints will be applied to protect the spinal cord and other nearby organs at risk.
Follow-up and Data Collection:
Following treatment, all participants will enter a comprehensive follow-up phase lasting up to two years. The schedule includes regular clinical evaluations, neurological assessments, and serial imaging (MRI and/or CT) to monitor treatment response and detect any potential late toxicities. Additionally, participants will complete validated questionnaires to assess changes in pain and health-related quality of life. Blood samples will be collected at baseline for correlative science studies to investigate potential genetic biomarkers (such as DDR2) and circulating factors that may predict treatment response or risk of skeletal side effects. This robust data collection will allow for a thorough comparison of the two treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose Spine Stereotactic Radiosurgery | Active comparator | Radiation: Spine Stereotactic Radiosurgery (SSRS)Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a dose of 16 Gray (Gy) in a single treatment session. |
| High Dose Spine Stereotactic Radiosurgery | Experimental | Radiation: Spine Stereotactic Radiosurgery (SSRS)Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a higher dose of 20 Gray (Gy) in a single treatment session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 18 years
Key exclusion criteria (16 listed)
- Prior radiotherapy or radiosurgery to the index spine(s)
- Serum creatinine > 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
- Inability to tolerate treatment procedure
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 |
|---|---|---|
| Spine Stereotactic Radiosurgery (SSRS)A non-invasive procedure that uses highly focused, high-energy radiation beams to precisely target metastatic tumors in the spine. The procedure is delivered using advanced techniques like Intensity Modulated Radiotherapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT/RapidArc), which allow the radiation dose to conform tightly to the shape of the tumor. This approach maximizes the dose to the cancer while carefully sparing surrounding healthy tissues, especially the critical spinal cord. The entire course of treatment is delivered in a single session, guided by on-board imaging to ensure sub-millimeter accuracy. | Radiation | High Dose Spine Stereotactic Radiosurgery, Standard Dose Spine Stereotactic Radiosurgery |
Primary outcome
Rate of Composite Treatment Failure at 12 Months
Time frame: At 12 months after the single fraction of Spine Stereotactic Radiosurgery (SSRS).
This is a composite endpoint that measures the percentage of participants in each arm who experience a treatment failure. A treatment failure is defined as the first occurrence of either of the following events: Clinically Significant Toxicity: The occurrence of a Grade 3 or higher adverse event that is definitely, probably, or possibly related to the radiation treatment. This includes specific neurological, musculoskeletal (e.g., spinal fracture), or gastrointestinal events as defined in the protocol. Local Tumor Progression: Unequivocal evidence of tumor growth at the treated spinal site, which is significant enough to warrant further medical intervention, such as spinal surgery or re-irradiation.
1 secondary outcome
Health-Related Quality of Life (EORTC QLQ-C15-PAL)
Time frame: Baseline, and at 1, 3, 6, 9, and 12 months post-treatment, and then every 3 months for a total follow-up period of up to 24 months.
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 26 Jun 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spine Stereotactic Radiosurgery (SSRS) in people with Spinal Neoplasms, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 9 inclusion and 16 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 phase mean?
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 Feng-Ming Hsu, M.D., Ph.D (886-2-23123456 ext. 62643, hsufengming@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Composite Treatment Failure at 12 Months (time frame: At 12 months after the single fraction of Spine Stereotactic Radiosurgery (SSRS).). 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 26 Jun 2025.