Hematopoietic and Lymphoid Cell NeoplasmNCT05178472
Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
A study testing Immunotherapy, Stereotactic Radiosurgery and Vertebroplasty in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine
- What is being tested?
- Immunotherapy, Stereotactic Radiosurgery and Vertebroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- 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
- At least 18 years of age and older with indeterminate Spine Metastasis.
- All patients with histology that requires stereotactic RT as a part of their treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Disease visualized by CT or MRI
- Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
- Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
- Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
Who cannot join
- Patients < 18 years of age
- Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
- Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
- Patients with symptomatic spinal cord compression requiring emergent surgery
- Pregnant or lactating women
- Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
- Patients with stable or unstable lesions based on SINS criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Dukagjin M. Blakaj, Dukagjin.blakaj@osumc.edu
Dukagjin M. Blakaj
About this study
Official title: Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the overall efficacy and safety of stereotactic radiosurgery (SRS) with or without vertebroplasty or separation surgery in patients with radiation resistant histologies metastatic to the spine with or without concurrent immunotherapy with PD1 blockade.
SECONDARY OBJECTIVES:
- To assess 6 month vertebral compression fracture (VCF) rate. II. To assess local control (LC) and distant disease control rates. III. To assess the progression free survival (PFS). IV. To assess the overall survival (OS). V. To assess potential vertebral compression fracture (VCF) risk in cancer patients with spinal metastases (SM).
VI. To assess changes in pain from baseline with patient reported measures, medication changes, and quality of life (QoL) measures.
EXPLORATORY OBJECTIVES:
- To assess changes in immune-stimulatory effect via Trex1 relative to radiation dose.
II. To evaluate whether changes in Trex1 correlates with PD-L1 expression. III. To validate known molecular signatures predicting metastatic potential and molecular mechanisms that have previously been documented.
IV. To develop novel molecular biomarker signatures that predict local spinal metastasis control.
- To evaluate molecular signatures at the time of spinal metastasis, and potentially define the "molecular evolution" of a tumor after treatment.
OUTLINE:
INDETERMINATE COHORT: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo vertebroplasty 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine
- Being tested
- Immunotherapy, Stereotactic Radiosurgery, Vertebroplasty
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyOther
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
Receive SOC immunotherapy
Stereotactic RadiosurgeryRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
Undergo SRS
VertebroplastyProcedure or surgery
Undergo vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vertebroplasty) | Experimental | Patients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Receives: Other: Immunotherapy; Radiation: Stereotactic Radiosurgery; Procedure: Vertebroplasty |
| Arm II (no vertebroplasty) | Active comparator | Patients receive standard of care immunotherapy IV every 2 weeks for up to 6 months and undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity. Receives: Other: Immunotherapy; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral compression fracture (VCF) rate
Will be summarized for all patients overall and by each cohort. The confidence interval of the overall VCF rate within 6 months will be calculated using binomial exact test for each cohort.
Measured: At 6 months
Local control
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Measured: At 6 months
Secondary outcomes (5)
Overall survival
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Measured: Up to 1 year
Progression-free survival
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Measured: Up to 1 year
Objective response rate
Will be summarized for all patients overall and by each cohort.
Measured: Up to 1 year
Change in health-related quality of life
Will be summarized for all patients overall and by each cohort and estimated using the linear mixed model for repeated measures for each group and overall.
Measured: Baseline up to 1 year
Abscopal effects
Will be summarized for all patients overall and by each cohort.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start27 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dukagjin Blakaj, Ohio State University Comprehensive Cancer Center
- Investigators
- Dukagjin M Blakaj, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178472
- Sponsor's protocol ID
- OSU-20048
- Other IDs
- NCI-2020-13764
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
- ClinicalTrials.gov ID
- NCT05178472
- Acronym / sponsor ID
- OSU-20048
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2022 (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 clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.
Detailed description
PRIMARY OBJECTIVE:
- To determine the overall efficacy and safety of stereotactic radiosurgery (SRS) with or without vertebroplasty or separation surgery in patients with radiation resistant histologies metastatic to the spine with or without concurrent immunotherapy with PD1 blockade.
SECONDARY OBJECTIVES:
- To assess 6 month vertebral compression fracture (VCF) rate. II. To assess local control (LC) and distant disease control rates. III. To assess the progression free survival (PFS). IV. To assess the overall survival (OS). V. To assess potential vertebral compression fracture (VCF) risk in cancer patients with spinal metastases (SM).
VI. To assess changes in pain from baseline with patient reported measures, medication changes, and quality of life (QoL) measures.
EXPLORATORY OBJECTIVES:
- To assess changes in immune-stimulatory effect via Trex1 relative to radiation dose.
II. To evaluate whether changes in Trex1 correlates with PD-L1 expression. III. To validate known molecular signatures predicting metastatic potential and molecular mechanisms that have previously been documented.
IV. To develop novel molecular biomarker signatures that predict local spinal metastasis control.
- To evaluate molecular signatures at the time of spinal metastasis, and potentially define the "molecular evolution" of a tumor after treatment.
OUTLINE:
INDETERMINATE COHORT: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo vertebroplasty 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vertebroplasty) | Experimental | Other: Immunotherapy, Radiation: Stereotactic Radiosurgery, Procedure: VertebroplastyPatients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm II (no vertebroplasty) | Active comparator | Other: Immunotherapy, Radiation: Stereotactic RadiosurgeryPatients receive standard of care immunotherapy IV every 2 weeks for up to 6 months and undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age and older with indeterminate Spine Metastasis.
- All patients with histology that requires stereotactic RT as a part of their treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Disease visualized by CT or MRI
- Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
Key exclusion criteria (7 listed)
- Patients < 18 years of age
- Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
- Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
- Patients with symptomatic spinal cord compression requiring emergent surgery
- Pregnant or lactating women
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 |
|---|---|---|
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyReceive SOC immunotherapy | Other | Arm I (vertebroplasty), Arm II (no vertebroplasty) |
| Stereotactic RadiosurgeryAlso: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic RadiotherapyUndergo SRS | Radiation | Arm I (vertebroplasty), Arm II (no vertebroplasty) |
| VertebroplastyUndergo vertebroplasty | Procedure or surgery | Arm I (vertebroplasty) |
Primary outcome
Vertebral compression fracture (VCF) rate
Time frame: At 6 months
Will be summarized for all patients overall and by each cohort. The confidence interval of the overall VCF rate within 6 months will be calculated using binomial exact test for each cohort.
Local control
Time frame: At 6 months
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
5 secondary outcomes
Overall survival
Time frame: Up to 1 year
Progression-free survival
Time frame: Up to 1 year
Objective response rate
Time frame: Up to 1 year
Change in health-related quality of life
Time frame: Baseline up to 1 year
Abscopal effects
Time frame: Up to 1 year
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 9 Apr 2026.
- The JameslineLink provided by the sponsor.
- 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.
The Ohio State University Comprehensive Cancer Center contact
Dukagjin M Blakaj, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunotherapy, Stereotactic Radiosurgery and Vertebroplasty in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center 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 9 Apr 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.
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 The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertebral compression fracture (VCF) rate (time frame: At 6 months). 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 9 Apr 2026.