Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue.
One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Karnofsky Performance Status (KPS) ≥ 70
RPA class 1 (KPS >70 AND controlled systemic disease) or RPA Class 2 (KPS >70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)
Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.
Disqualifiers
Lesions at C1-2 or S1-Coccyx.
Hematologic malignancies including lymphoma and myeloma.
Multiple primary cancers.
Primary neoplasms of the spine
Trial design
Design model
Parallel
Treatments tested in this trial
Diagnostic MRI
DeviceDiagnostic MRI
Planning MRI
DevicePlanning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
Simulation CT
Other interventionSimulation CT is obtained (1.5 mm slice thickness)
QOL assessment
Other interventionQOL assessment
Brief pain inventory (BPI)
Other interventionBrief pain inventory (BPI), including narcotic assessment
sSRS in 1 fraction
RadiationsSRS 18 Gy in 1 fraction
sSRS in 2 fraction
RadiationsSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Single fractionExperimental treatment 6 interventions
Group B: Arm 2 - Two fractionActive comparator 6 interventions
Trial outcomes
Primary outcomes
1
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS Each treated vertebra will be assessed individually for VCF during radiologic follow-up
Time frame
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)Secondary outcomes
1
Local control (LC) as defined as absence of local progression of disease In the event of disease progression, all cases will be reviewed at the multi-disciplinary spine tumor board for a consensus recommendation
LC as defined as absence of local progression of disease, which include the following: 1. Gross unequivocal increase in tumor volume or linear dimension. 2. Any new or progressive tumor within the epidural space. 3. Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.
Time frame
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)2
Pain control (PC) as assessed by the Brief Pain Inventory (BPI)
PC at each treated vertebral level assessed by the BPI \[9 item questionnaire (range: 0-10), higher scores = worse pain\], then defined by RTOG 0631 as follows: Complete relief (CR): Pain score of 0 at index site 3 mo post-treatment. CR is requisite of no increase in narcotic analgesics. Partial relief (PR): Reduction in BPI of ≥ 3 points at index site, provided other treated lesions have increased in pain score and participant did not require increase in narcotic analgesics for site of interest. Participants needing increase in narcotics for site will not be scored as having PR. Those needing increase in narcotics for a distant site will remain eligible for CR/PR. Stable response (SR): Post-treatment pain score same as or within 2 points of baseline score at index site with no increase in narcotic analgesics for site of interest. Progressive pain: Post-treatment increase of at least 3 points from baseline pain score at index site or increase in narcotics for site of interest.
Time frame
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)3
Quality of life (QOL) assessed by EORTC QLQ-C30 (with BM22)
Quality of life as measured by (EORTC QOL-C30) - 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")
Time frame
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)4
Toxicity as assessed by CTCAE V. 5.0
Toxicity as assessed by criteria in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Rates of grade 1-5 toxicities will be reported
Time frame
At follow-up MRI (1 month, 3 months, 6 months and 12 months after treatment)Sponsors and contacts
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Source ClinicalTrials.gov