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NCT Number: NCT06173401

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-fraction spine SRS

Radiation

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

Multi-fraction spine SRS

Radiation

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

Primary outcomes

  1. Tumor control

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 2 years

    To compare health-related quality of life (EQ-5D-3L) following SRS and assess patient-reported health related quality of life pertaining to mobility, self-care, usual activities, pain, and anxiety.

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

    Time frame: 2 years

    To compare health-related quality of life (EORTC QLQ-C30) following SRS and assess patient-reported health related quality of life pertaining to overall health and quality of daily life.

  3. EORTC QLQ-BM22 health-related quality of life questionnaire

    Time frame: 2 years

    To compare health-related quality of life (EORTC QLQ-BM22) following SRS and assess patient-reported health related quality of life pertaining to pain associated with performing activities of daily life.

  4. Pain Score

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

    Pain associated with the treated area will be assessed by asking patients to rate their pain on a 0-10 scale ("no pain" to "pain as bad as you can imagine")

  5. Medication Intake

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

    Collect medications taken within the last 24 hours.

  6. Number of participants with CTCAE grade grade 2 or higher adverse effects

    Time frame: 1 year

    To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS

  7. Rate of vertebral compression fracture

    Time frame: 1 year

    To determine 1-year rate of vertebral compression fracture (VCF), following SRS

  8. Rate of local failure

    Time frame: 2 years

    To determine 2-year rate of local failure following SRS

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Yauger

CONTACT

[email protected]

650-498-5271

Kelly Huang

CONTACT

[email protected]

650-724-4606

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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