RECRUITING

Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

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 study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

Official Title

Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column

Quick Facts

Study Start:2021-03-14
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04802603

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. * Zubrod Performance Status 0-2
  2. * Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
  3. * Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
  4. * Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
  5. * For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
  6. * Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
  1. * Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
  2. * Non-ambulatory patients
  3. * \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
  4. * Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
  5. * Rapid neurologic decline
  6. * Patients for whom an MRI of the spine is medically contraindicated
  7. * Pregnant women

Contacts and Locations

Study Contact

Rupesh Kotecha, MD
CONTACT
786-596-2000
RupeshK@baptisthealth.net
Antoinette Pimentel
CONTACT
17865962000
antoinette.pimentel@baptisthealth.net

Principal Investigator

Rupesh Kotecha, MD
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute (MCI) at Baptist Health, Inc.

Study Locations (Sites)

Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

  • Rupesh Kotecha, MD, PRINCIPAL_INVESTIGATOR, Miami Cancer Institute (MCI) at Baptist Health, Inc.

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 Date2021-03-14
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-03-14
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Localized Metastasis
  • Spinal Column

Additional Relevant MeSH Terms

  • Spine Metastases
  • Metastasis Spine