Spinal MetastasesPRESTRASMNCT07135817
Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
A study testing Preoperative Stereotactic Body Radiotherapy (SBRT) and Spinal Surgery for Decompression and/or Stabilization in people with Spinal Metastases and Solid Tumor Cancer, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases, Solid Tumor Cancer
- What is being tested?
- Preoperative Stereotactic Body Radiotherapy (SBRT) and Spinal Surgery for Decompression and/or Stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Goettingen
Göttingen, 37073
Anna-Lena Simmert, +49 551 39 64567, anna-lena.simmert@med.uni-goettingen.de
About this study
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:
Read more
- 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)
- Conditions
- Spinal Metastases, Solid Tumor Cancer
- Being tested
- Preoperative Stereotactic Body Radiotherapy (SBRT), Spinal Surgery for Decompression and/or Stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Stereotactic Body Radiotherapy (SBRT)Radiation
Hypofractionated 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 StabilizationProcedure or surgery
Surgical 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)
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Stereotactic Body Radiotherapy + Surgery | Experimental | Participants will receive hypofractionated Stereotactic Body Radiotherapy (SBRT) to spinal metastases in 1-3 fractions within one week after informed consent. SBRT will be planned using MRI co-registered with planning CT and delivered following institutional immobilization standards and ESTRO guidelines. Surgical intervention will follow within a maximum of 10 days after informed consent and includes decompression of the spinal canal and/or dorsal instrumentation, depending on clinical indication. Receives: Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT); Procedure: Spinal Surgery for Decompression and/or Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control
Measured: 3 months after treatment
Secondary outcomes (7)
Local Tumor Control
Measured: 6 months after treatment
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").
Measured: at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment
Wound Healing Complications at Hospital Discharge
Measured: at discharge from initial hospitalization (typically within 5-10 days after surgery)
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.
Measured: 3 and 6 months after treatment
EORTC QLQ-BM22 Scores
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Bone Metastases module (EORTC QLQ-BM22) is a validated 22-item patient-reported outcome measure designed to assess quality of life specifically in patients with bone metastases. It includes functional and symptom domains. Scores range from 0 to 100. Higher scores in symptom scales indicate worse symptoms; higher scores in functional scales indicate better function.
Measured: 3 and 6 months after treatment
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a validated patient-reported outcome questionnaire used to assess the degree of disability and functional impairment due to low back pain. It consists of 10 items covering activities of daily living. Scores range from 0% to 100%, with higher scores indicating greater disability.
Measured: 3 and 6 months after treatment
Number of participants with radiologically confirmed instrumentation failure
Instrumentation failure will be assessed based on postoperative spinal imaging (CT and MRI). Failure is defined as signs of implant loosening, breakage, displacement, or the need for surgical revision. Imaging will be evaluated by a radiologist according to institutional standards. The number of affected participants will be reported.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Rami El Shafie, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135817
- Sponsor's protocol ID
- 14/5/24
- Acronym
- PRESTRASM
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
- ClinicalTrials.gov ID
- NCT07135817
- Acronym / sponsor ID
- PRESTRASM / 14/5/24
- Conditions
- Spinal Metastases, Solid Tumor Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Stereotactic Body Radiotherapy + Surgery | Experimental | Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT), Procedure: Spinal Surgery for Decompression and/or StabilizationParticipants will receive hypofractionated Stereotactic Body Radiotherapy (SBRT) to spinal metastases in 1-3 fractions within one week after informed consent. SBRT will be planned using MRI co-registered with planning CT and delivered following institutional immobilization standards and ESTRO guidelines. Surgical intervention will follow within a maximum of 10 days after informed consent and includes decompression of the spinal canal and/or dorsal instrumentation, depending on clinical indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Stereotactic Body Radiotherapy (SBRT)Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines. | Radiation | Hypofractionated Stereotactic Body Radiotherapy + Surgery |
| Spinal Surgery for Decompression and/or StabilizationSurgical 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) | Procedure or surgery | Hypofractionated Stereotactic Body Radiotherapy + Surgery |
Primary outcome
Local Tumor Control
Time frame: 3 months after treatment
7 secondary outcomes
Local Tumor Control
Time frame: 6 months after treatment
Pain relief
Time frame: at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment
Wound Healing Complications at Hospital Discharge
Time frame: at discharge from initial hospitalization (typically within 5-10 days after surgery)
EORTC QLQ-C30 Scores
Time frame: 3 and 6 months after treatment
EORTC QLQ-BM22 Scores
Time frame: 3 and 6 months after treatment
Oswestry Disability Index (ODI)
Time frame: 3 and 6 months after treatment
Number of participants with radiologically confirmed instrumentation failure
Time frame: 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Stereotactic Body Radiotherapy (SBRT) and Spinal Surgery for Decompression and/or Stabilization in people with Spinal Metastases and Solid Tumor Cancer, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla Marie Zwerenz, Dr. med. (+49 551 39 64501, carlamarie.zwerenz@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.