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NCT Number: NCT07135817

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

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)

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Key information

Conditions

Spinal Metastases Solid Tumor Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Goettingen

Göttingen, 37073, Germany

Location status: Recruiting

Location contact

Anna-Lena Simmert

CONTACT

[email protected]

+49 551 39 64567

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 Stabilization

Procedure

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)

Primary outcomes

  1. Local Tumor Control

    Time frame: 3 months after treatment

Secondary outcomes

  1. Local Tumor Control

    Time frame: 6 months after treatment

  2. Pain relief

    Time frame: at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment

    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").

  3. 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

    Time frame: 3 and 6 months after treatment

    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.

  5. EORTC QLQ-BM22 Scores

    Time frame: 3 and 6 months after treatment

    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.

  6. Oswestry Disability Index (ODI)

    Time frame: 3 and 6 months after treatment

    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.

  7. Number of participants with radiologically confirmed instrumentation failure

    Time frame: 6 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Marie Zwerenz, Dr. med.

CONTACT

[email protected]

+49 551 39 64501

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Acronym: PRESTRASM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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