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

NCT ID: NCT05178472

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-12-31

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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

V. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (vertebroplasty)

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.

Group Type: EXPERIMENTAL

Immunotherapy

Intervention Type: OTHER

Receive SOC immunotherapy

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo SRS

Vertebroplasty

Intervention Type: PROCEDURE

Undergo vertebroplasty

Arm II (no vertebroplasty)

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.

Group Type: ACTIVE_COMPARATOR

Immunotherapy

Intervention Type: OTHER

Receive SOC immunotherapy

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo SRS

Interventions

Immunotherapy

Receive SOC immunotherapy

Intervention Type: OTHER

Stereotactic Radiosurgery

Undergo SRS

Intervention Type: RADIATION

Vertebroplasty

Undergo vertebroplasty

Intervention Type: PROCEDURE

Other Intervention Names

Immunological; Immunological Therapy; Immunologically Directed Therapy; Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; Stereotactic Radiation Therapy; Stereotactic Radiotherapy

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age and older with indeterminate Spine Metastasis.
• All patients with metastatic radiation resistant histologies to the spine (such as Non-small cell Lung cancer, Melanoma, Colorectal, Sarcoma, head and neck, Esophageal, Gallbladder, Liver, Pancreatic, Prostate, Breast, Thyroid, Renal Cell Carcinoma)
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Dukagjin Blakaj

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dukagjin M Blakaj, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

The Ohio State University Comprehensive Cancer Center

Role: CONTACT

OSUCCCClinicaltrials@osumc.edu

800-293-5066

Facility Contacts

Dukagjin M. Blakaj

Role: primary

Dukagjin.blakaj@osumc.edu

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2020-13764

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-20048

Identifier Type: -

Identifier Source: org_study_id