Comparing single vs multiple sessions of spine radiosurgery for spinal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of single-fraction versus multi-fraction stereotactic radiosurgery (SRS) in treating spinal metastases. Patients will be randomly assigned to receive either 22 Gy in one session or 28 Gy in two sessions of SRS. The study focuses on determining which approach leads to better local tumor control. Eligible participants include adults with confirmed metastatic cancer affecting the cervical, thoracic, or lumbar spine, requiring treatment at one to three spinal sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University School of Medicine
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Erqi Pollom, MD — Stanford University
• Study coordinator: Kelly Huang
• Email: kelhuang@stanford.edu
• Phone: 650-724-4606

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pre-surgery focused radiation for spinal metastases.

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• Evaluating autologous blood transfusion in spinal surgery for lung cancer with spinal metastasis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.