Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases (PRESTRASM)

University Medical Center Goettingen

Status: Enrolling

Conditions: Solid Tumor Cancer; Spinal Metastases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07135817

14/5/24

Details and patient eligibility

About

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)

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hypofractionated Stereotactic Body Radiotherapy + Surgery

Experimental group

Description:

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.

Treatment:

Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)

Procedure: Spinal Surgery for Decompression and/or Stabilization