Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)

NCT05178472 | Recruiting DMC

• 2 other identifiers: OSU-20048NCI-2020-13764
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Spine

Outcome Measures

Primary Outcomes (2)

• 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.

  At 6 months

• Local control

  Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.

  At 6 months

Secondary Outcomes (5)

• Overall survival

  Up to 1 year

• Progression-free survival

  Up to 1 year

• Objective response rate

  Up to 1 year

• Change in health-related quality of life

  Baseline up to 1 year

• Abscopal effects

  Up to 1 year

Study Arms (2)

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.

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.

Other: Immunotherapy; Radiation: Stereotactic Radiosurgery

Interventions

Immunotherapy OTHER

Receive SOC immunotherapy

Also known as: Immunological, Immunological Therapy, Immunologically Directed Therapy

Arm I (vertebroplasty); Arm II (no vertebroplasty)

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy

Arm I (vertebroplasty); Arm II (no vertebroplasty)

Vertebroplasty PROCEDURE

Undergo vertebroplasty

Arm I (vertebroplasty)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Immunotherapy; Adjuvants, Immunologic; Radiosurgery; Vertebroplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Cementoplasty; Orthopedic Procedures

Study Officials

• Dukagjin M Blakaj, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: March 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)