Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: 2023-03-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov