RECRUITING

Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

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Conditions

Spinal Metastasesspine stereotactic radiosurgerycervicallumbarthoracicmetastases

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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

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Official Title

A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)

Quick Facts

Study Start:2023-12-18
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06173401

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. * Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
  2. * Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
  3. * Patients will have 1 to 3 separate spinal sites that require treatment.
  4. * Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
  5. * ECOG 0-2
  6. * Negative serum or urine pregnancy test within 14 days prior to enrollment for women of childbearing potential or who are not postmenopausal
  7. * Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  8. * Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document
  1. * Prior or planned radiation off study within or overlapping with study treatment site
  2. * Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
  3. * Pediatric patients (age \<18 years old), pregnant women, and nursing patients will be excluded
  4. * Histology's of myeloma or lymphoma
  5. * Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
  6. * Prior surgery to spinal site intended to be treated with protocol SRS
  7. * Excluded those with SINS 13-18

Contacts and Locations

Study Contact

Jillian Skerchak
CONTACT
650-721-4072
jskerch1@stanford.edu
Kelly Huang
CONTACT
650-724-4606
kelhuang@stanford.edu

Study Locations (Sites)

Stanford University School of Medicine
Palo Alto, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

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 Date2023-12-18
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-12-18
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • spine stereotactic radiosurgery
  • cervical
  • lumbar
  • thoracic
  • metastases

Additional Relevant MeSH Terms

  • Spinal Metastases