Spinal MetastasesPhase 3NCT06173401
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
A Phase 3 study testing Single-fraction spine SRS and Multi-fraction spine SRS in people with Spinal Metastases, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Single-fraction spine SRS and Multi-fraction spine SRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to Dec 2028
- Phase
- Phase 3
- 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
- Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
- Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
- Patients will have 1 to 3 separate spinal sites that require treatment.
- Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
- ECOG 0-2
- Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal
- people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document
Who cannot join
- Prior or planned radiation off study within or overlapping with study treatment site
- Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
- Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
- Histology's of myeloma or lymphoma
- Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
- Prior surgery to spinal site intended to be treated with protocol SRS
- Excluded those with SINS 13-18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94305
Kelly Huang, 650-724-4606, kelhuang@stanford.edu
Alyssa Yauger, 650-498-5271, ayauger@stanford.edu
About this study
Official title: A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.
- Conditions
- Spinal Metastases
- Being tested
- Single-fraction spine SRS, Multi-fraction spine SRS
- Keywords
- spine stereotactic radiosurgery, cervical, lumbar, thoracic, metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-fraction spine SRSRadiation
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Multi-fraction spine SRSRadiation
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
| Study group | Role | What they receive |
|---|---|---|
| Single-fraction spine SRS | Experimental | Single-fraction spine SRS (22 Gy x 1) Receives: Radiation: Single-fraction spine SRS |
| Multi-fraction spine SRS | Experimental | Multi-fraction spine SRS (14 Gy x 2) Receives: Radiation: Multi-fraction spine SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor control
To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.
Measured: 1 year
Secondary outcomes (8)
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
To compare health-related quality of life (EQ-5D-3L) following SRS and assess patient-reported health related quality of life pertaining to mobility, self-care, usual activities, pain, and anxiety.
Measured: 2 years
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
To compare health-related quality of life (EORTC QLQ-C30) following SRS and assess patient-reported health related quality of life pertaining to overall health and quality of daily life.
Measured: 2 years
EORTC QLQ-BM22 health-related quality of life questionnaire
To compare health-related quality of life (EORTC QLQ-BM22) following SRS and assess patient-reported health related quality of life pertaining to pain associated with performing activities of daily life.
Measured: 2 years
Pain Score
Pain associated with the treated area will be assessed by asking patients to rate their pain on a 0-10 scale ("no pain" to "pain as bad as you can imagine")
Measured: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Medication Intake
Collect medications taken within the last 24 hours.
Measured: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Number of participants with CTCAE grade grade 2 or higher adverse effects
To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS
Measured: 1 year
Rate of vertebral compression fracture
To determine 1-year rate of vertebral compression fracture (VCF), following SRS
Measured: 1 year
Rate of local failure
To determine 2-year rate of local failure following SRS
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 posted15 Dec 2023
- Study start18 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Stanford 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erqi Pollom, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173401
- Sponsor's protocol ID
- IRB-72248
- Other IDs
- BRN0060, NCI-2024-00695
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
- ClinicalTrials.gov ID
- NCT06173401
- Acronym / sponsor ID
- IRB-72248
- Conditions
- Spinal Metastases
- Keywords
- spine stereotactic radiosurgery, cervical, lumbar, thoracic, metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Dec 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.
The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-fraction spine SRS | Experimental | Radiation: Single-fraction spine SRSSingle-fraction spine SRS (22 Gy x 1) |
| Multi-fraction spine SRS | Experimental | Radiation: Multi-fraction spine SRSMulti-fraction spine SRS (14 Gy x 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
- Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
- Patients will have 1 to 3 separate spinal sites that require treatment.
- Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
- ECOG 0-2
Key exclusion criteria (7 listed)
- Prior or planned radiation off study within or overlapping with study treatment site
- Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
- Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
- Histology's of myeloma or lymphoma
- Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
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 |
|---|---|---|
| Single-fraction spine SRSTreatment Arm 1: Single-fraction spine SRS (22 Gy x 1) | Radiation | Single-fraction spine SRS |
| Multi-fraction spine SRSTreatment Arm 2: Multi-fraction spine SRS (14 Gy x 2) | Radiation | Multi-fraction spine SRS |
Primary outcome
Tumor control
Time frame: 1 year
To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.
8 secondary outcomes
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
Time frame: 2 years
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
Time frame: 2 years
EORTC QLQ-BM22 health-related quality of life questionnaire
Time frame: 2 years
Pain Score
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Medication Intake
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Number of participants with CTCAE grade grade 2 or higher adverse effects
Time frame: 1 year
Rate of vertebral compression fracture
Time frame: 1 year
Rate of local failure
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 27 Jul 2026.
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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.
Erqi Pollom, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-fraction spine SRS and Multi-fraction spine SRS in people with Spinal Metastases, run by Stanford University at 1 site in United States.
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 8 inclusion and 7 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 27 Jul 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Kelly Huang (650-724-4606, kelhuang@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor control (time frame: 1 year). 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 27 Jul 2026.