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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06173401
Phase
PHASE3
Status
Recruiting
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Conditions

  • Spinal Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Dec 18, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
274 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single-fraction spine SRS
    Single-fraction spine SRS (22 Gy x 1)
  • Experimental: Multi-fraction spine SRS
    Multi-fraction spine SRS (14 Gy x 2)

Primary Outcome Measure

Tumor control [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94305
Kelly Huang
[email protected]
650-724-4606
Alyssa Yauger
[email protected]
650-498-5271
Erqi L Pollom, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University School of Medicine· Palo Alto, CA

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