Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen
About this trial
The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases.
The main questions this study aims to answer are:
* Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI/CT scan at 3 and 6 months postoperatively? * What are the postoperative outcomes in terms of pain intensity, functional status and quality of life?
Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention.
Participants will undergo preoperative and follow-up assessments, including:
* MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size * Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable) * A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities * Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for surgical treatment of a spinal tumor
Age: older or 18 years
Estimated survival > 6 months
The patient is able to understand the nature, significance and scope of the clinical study in the context of patient information and to base the decision to participate in the study on this.
Disqualifiers
Age: < 18 years
Motor deficit or loss of bladder and bowel control that urges an emergency surgical decompression
Tumor extent does not allow hypofractioned SBRT (1-3 fractions)
Trial design
Design model
Single group
Treatments tested in this trial
Preoperative Stereotactic Body Radiotherapy (SBRT)
RadiationHypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.
Spinal Surgery for Decompression and/or Stabilization
Procedure/SurgerySurgical intervention is performed following SBRT, based on clinical indication. It includes decompression of the spinal canal in cases of spinal cord or nerve compression (via laminectomy and/or foraminotomy), and/or dorsal instrumentation for unstable spines using pedicle screws guided by a neuronavigation system (Brainlab, Munich, Germany)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Hypofractionated Stereotactic Body Radiotherapy + SurgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Local Tumor Control
Time frame
3 months after treatmentSecondary outcomes
1
Local Tumor Control
Time frame
6 months after treatment2
Pain relief
Pain rating measured by numerical rating scale (zero to ten): This is conducted by asking the patients to rate their 1) present pain, as well as 2) the worst pain they had experienced in the last 24 hours, and 3) the average pain experienced in the last 24 hours on a numeric rating scale (NRS: 0 = "no pain", 10 = "worst pain imaginable").
Time frame
at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment3
Wound Healing Complications at Hospital Discharge
Time frame
at discharge from initial hospitalization (typically within 5-10 days after surgery)4
EORTC QLQ-C30 Scores
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a validated 30-item questionnaire to assess cancer patients' general health status and quality of life. Scores range from 0 to 100. For global health and functioning scales, higher scores indicate better outcomes. For symptom scales, higher scores indicate worse symptoms.
Time frame
3 and 6 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov