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RecruitingInterventionalPhase 3

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

NCT ID: NCT06173401Sponsor: Stanford UniversityLast updated: 2025-07-16

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.

Arms & interventions

  • RadiationSingle-fraction spine SRS

    Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)

  • RadiationMulti-fraction spine SRS

    Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)

Outcome measures

Primary

  • Tumor control

    To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.

    Time frame: 1 year

Secondary

  • Euro-QOL EQ-5D-3L health-related quality of life questionnaire

    Time frame: 2 years

  • European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score

    Time frame: 2 years

  • EORTC QLQ-BM22 health-related quality of life questionnaire

    Time frame: 2 years

  • Pain Score

    Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS

  • Medication Intake

    Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS

  • Number of participants with CTCAE grade grade 2 or higher adverse effects

    Time frame: 1 year

  • Rate of vertebral compression fracture

    Time frame: 1 year

  • Rate of local failure

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Stanford University School of Medicine

Palo Alto, California, 94305

Recruiting
Kelly Huang · Contact
Alyssa Yauger · Contact
Erqi L Pollom, M.D. · Principal Investigator
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases | Cancerify