NCT07135817 Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
| NCT ID | NCT07135817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Goettingen |
| Condition | Spinal Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07135817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07135817 currently recruiting?
Yes, NCT07135817 is actively recruiting participants. Contact the research team at carlamarie.zwerenz@med.uni-goettingen.de for enrollment information.
Where is the NCT07135817 trial being conducted?
This trial is being conducted at Göttingen, Germany.
Who is sponsoring the NCT07135817 clinical trial?
NCT07135817 is sponsored by University Medical Center Goettingen. The trial plans to enroll 20 participants.