Study Comparing Single vs. Multiple Session Spine Radiosurgery for Spinal Tumors

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06173401

Provider View

This clinical trial is exploring whether giving spine radiosurgery in one session or two sessions is more effective at controlling tumors in patients with spinal metastases. Participants will be randomly assigned to receive either one high-dose session or two lower-dose sessions of radiosurgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if treating spinal tumors with radiosurgery in one session is as effective as treating them in two sessions. Radiosurgery is a precise form of radiation therapy that targets tumors in the spine. Patients will be randomly assigned to receive either a single session of 22 Gy or two sessions totaling 28 Gy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of cancer that has spread to the spine.
  • Patients with tumors in the cervical, thoracic, or lumbar spine that need treatment.
  • Patients can have 1 to 3 separate spinal areas that require treatment.
  • Each area to be treated will cover 1-2 connected vertebrae.
  • Patients must be in relatively good health, with an ECOG performance status of 0 to 2.
  • Women who can become pregnant must have a negative pregnancy test within 14 days before joining the study.
  • Participants who are sexually active must agree to use effective birth control.
  • Must be able to understand and sign the consent form, either personally or through a legal representative.

Exclusion Criteria

  • Patients who have had or plan to have radiation treatment outside of the study in the same area.
  • Patients who cannot have an MRI or CT scan. Those with a pacemaker can have a CT scan instead of an MRI.
  • Children under 18, pregnant women, and nursing mothers cannot participate.
  • Patients with myeloma or lymphoma.
  • Patients with severe weakness, bladder or bowel issues related to the spinal area to be treated.
  • Patients who have had surgery on the spinal area intended for treatment in this study.
  • Patients with a Spinal Instability Neoplastic Score (SINS) of 13-18.

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