Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

NCT07135817 | Recruiting

• 1 other identifier: 14/5/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Spinal Metastases; Solid Tumor Cancer

Outcome Measures

Primary Outcomes (1)

• Local Tumor Control

  3 months after treatment

Secondary Outcomes (7)

• Local Tumor Control

  6 months after treatment

• Pain relief

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

• Wound Healing Complications at Hospital Discharge

  at discharge from initial hospitalization (typically within 5-10 days after surgery)

• EORTC QLQ-C30 Scores

  3 and 6 months after treatment

• EORTC QLQ-BM22 Scores

  3 and 6 months after treatment

Study Arms (1)

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.

Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT); Procedure: Spinal Surgery for Decompression and/or Stabilization

Interventions

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.

Hypofractionated Stereotactic Body Radiotherapy + Surgery

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)

Hypofractionated Stereotactic Body Radiotherapy + Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Goettingen

Göttingen, 37073, Germany

RECRUITING

Central Study Contacts

Carla Marie Zwerenz, Dr. med.

CONTACT

+49 551 39 64501; carlamarie.zwerenz@med.uni-goettingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

DE (1)