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

Stanford University

Status and phase: Enrolling; Phase 3

Conditions: Spinal Metastases

Treatments: Radiation: Multi-fraction spine SRS; Radiation: Single-fraction spine SRS

Study type: Interventional

Funder types: Other

Identifiers

NCT06173401

BRN0060 (Other Identifier)

NCI-2024-00695 (Registry Identifier)

IRB-72248

Details and patient eligibility

About

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.

Enrollment: 274 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups

Single-fraction spine SRS

Experimental group

Description:

Single-fraction spine SRS (22 Gy x 1)

Treatment:

Radiation: Single-fraction spine SRS

Multi-fraction spine SRS

Experimental group

Description:

Multi-fraction spine SRS (14 Gy x 2)

Treatment:

Radiation: Multi-fraction spine SRS