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

ConditionSpinal Metastases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-fraction spine SRS

    Radiation

    Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)

  • Multi-fraction spine SRS

    Radiation

    Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)

Treatment groups

274 Participants
are divided into 2 treatment groups
Group A: Single-fraction spine SRSExperimental treatment 1 intervention
Group B: Multi-fraction spine SRSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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")

Time frame
1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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