RECRUITING

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

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Conditions

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid NeoplasmMetastatic Malignant Neoplasm in the Spine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-27
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05178472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age and older with indeterminate Spine Metastasis.
  2. * 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)
  3. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  4. * Disease visualized by CT or MRI
  5. * Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
  6. * Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
  7. * 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
  8. * 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
  1. * Patients \< 18 years of age
  2. * Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
  3. * 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.
  4. * Patients with symptomatic spinal cord compression requiring emergent surgery
  5. * Pregnant or lactating women
  6. * Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
  7. * Patients with stable or unstable lesions based on SINS criteria

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Dukagjin M Blakaj, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Dukagjin M Blakaj, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-03-27
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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