Clinical trial NCT06173401: Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Official title: A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Spinal Metastases
Keywords: spine stereotactic radiosurgery
cervical
lumbar
thoracic
metastases
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Tumor control
timeFrame: 1 year
Secondary outcomes:
measure: Euro-QOL EQ-5D-3L health-related quality of life questionnaire
timeFrame: 2 years
measure: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
timeFrame: 2 years
measure: EORTC QLQ-BM22 health-related quality of life questionnaire
timeFrame: 2 years
measure: Pain Score
timeFrame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
measure: Medication Intake
timeFrame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
measure: Number of participants with CTCAE grade grade 2 or higher adverse effects
timeFrame: 1 year
measure: Rate of vertebral compression fracture
timeFrame: 1 year
measure: Rate of local failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Erqi Pollom, MD
role: PRINCIPAL_INVESTIGATOR
References: