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

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.

Conditions

Spinal Metastases

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spinal Metastases
Intervention / Treatment

-

Contacts and Locations

Palo Alto

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Study Record Dates

2028-12