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NCT06173401 | RECRUITING | Spinal Metastases

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

Stanford University

Brief Summary:

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.

Condition or disease

Spinal Metastases

Intervention/treatment

Single-fraction spine SRS

Multi-fraction spine SRS

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 274 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Actual Study Start Date : 2023-12-18
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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 people of childbearing potential or who are not postmenopausal
  • * people 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
Exclusion Criteria
  • * 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
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Location Details

NCT06173401

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How to Participate

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Locations

RECRUITING

United States, California

Stanford University School of Medicine

Palo Alto, California, United States, 94305