Comparing single vs multiple sessions of spine radiosurgery for spinal metastases

A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)

This study tests whether one session or two sessions of targeted radiation therapy can better control tumors in the spine for adults with metastatic cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06173401 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic cancer and 1 to 3 spinal sites needing treatment.

Not a fit: Patients with prior radiation treatment at the study site or those unable to undergo necessary imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing treatment for spinal metastases, potentially improving patient outcomes.

How similar studies have performed: Previous studies have explored various approaches to radiosurgery, but this specific comparison of single vs multi-fraction SRS is novel.

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

Where this trial is running

Palo Alto, California

• Stanford University School of Medicine — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Erqi Pollom, MD — Stanford University
• Study coordinator: Kelly Huang

Conditions: Spinal Metastases, spine stereotactic radiosurgery, cervical, lumbar, thoracic, metastases