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

Launched by STANFORD UNIVERSITY · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to deliver a type of radiation therapy called Stereotactic Radiosurgery (SRS) for patients with spinal metastases, which are cancer cells that have spread to the spine. The researchers want to find out if giving the radiation in two smaller doses (28 Gy in 2 fractions) is more effective at controlling the tumor compared to a single larger dose (22 Gy in 1 fraction). The trial is currently looking for participants aged 18 and older who have been diagnosed with metastatic cancer and have 1 to 3 areas in their spine that need treatment.

To be eligible for this trial, participants must have confirmed metastatic cancer and be able to understand and sign an informed consent form. They should not have had previous radiation treatment in the same area or certain conditions that affect their ability to undergo imaging tests. Participants can expect to receive either of the radiation treatments and will be monitored for their response to the therapy. It’s important to note that the trial is recruiting patients of all genders and aims to help improve treatment options for those with spinal metastases.

Gender

ALL

Eligibility criteria

• 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