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

Spinal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173401
• Other study ID #: IRB-72248
• Secondary ID: BRN0060
• Status: Recruiting
• Phase: Phase 3
• Start date: December 18, 2023
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Aniket Pratapneni
• Phone: 650-723-3110
• Email: apratap1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 women of childbearing potential or who are not postmenopausal

• Women 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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• Single-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
• Multi-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor control	To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.	1 year
Secondary	Euro-QOL EQ-5D-3L health-related quality of life questionnaire	To compare health-related quality of life (EQ-5D-3L) following SRS and assess patient-reported health related quality of life pertaining to mobility, self-care, usual activities, pain, and anxiety.	2 years
Secondary	European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score	To compare health-related quality of life (EORTC QLQ-C30) following SRS and assess patient-reported health related quality of life pertaining to overall health and quality of daily life.	2 years
Secondary	EORTC QLQ-BM22 health-related quality of life questionnaire	To compare health-related quality of life (EORTC QLQ-BM22) following SRS and assess patient-reported health related quality of life pertaining to pain associated with performing activities of daily life.	2 years
Secondary	Pain Score	Pain associated with the treated area will be assessed by asking patients to rate their pain on a 0-10 scale ("no pain" to "pain as bad as you can imagine")	1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Secondary	Medication Intake	Collect medications taken within the last 24 hours.	1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Secondary	Number of participants with CTCAE grade grade 2 or higher adverse effects	To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS	1 year
Secondary	Rate of vertebral compression fracture	To determine 1-year rate of vertebral compression fracture (VCF), following SRS	1 year
Secondary	Rate of local failure	To determine 2-year rate of local failure following SRS	2 years