Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07135817

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Led by University Medical Center Goettingen · Updated on 2025-08-22

20

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the use of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) for patients undergoing surgery to treat spinal metastases, which are tumors that have spread to the spine from solid cancers. The study aims to determine if SBRT before surgery can control tumor growth at the affected spinal segments and improve postoperative outcomes such as pain, function, and quality of life. Participants will receive hypofractionated SBRT delivered in 1 to 3 sessions within one week after consenting, planned using MRI combined with CT scans and performed according to established institutional and ESTRO guidelines. Surgical treatment, which may include spinal canal decompression and/or stabilization with instrumentation, will occur within 10 days following consent, tailored to the patient's clinical needs. Throughout the study, participants will undergo MRI and CT scans before surgery, shortly after, and at 3 and 6 months post-surgery to assess tumor size and local control. They will complete questionnaires evaluating pain intensity, physical limitations, and overall quality of life. Researchers will also monitor wound healing, functional status, and any surgical instrumentation issues up to 6 months after treatment. The involvement includes preoperative and multiple follow-up assessments to measure safety and effectiveness outcomes over time.

CONDITIONS

Brief Title

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for surgical treatment of a spinal tumor
  • Age 18 years or older
  • Estimated survival longer than 6 months
  • Ability to understand the study and decide to participate
Not Eligible

You will not qualify if you...

  • Age younger than 18 years
  • Motor deficit or loss of bladder and bowel control requiring emergency surgical decompression
  • Tumor extent unsuitable for hypofractionated SBRT in 1-3 fractions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Preoperative Stereotactic Body Radiotherapy (SBRT)

Duration - Up to 1 week

Participants receive hypofractionated SBRT to spinal metastases in 1 to 3 fractions within one week after informed consent, planned using MRI and CT imaging.

1 to 3 visits (in-person)

Surgery and Immediate Post-operative Care

Duration - Typically within 10 days after informed consent

Surgical intervention is performed following SBRT, including decompression of the spinal canal and/or dorsal instrumentation depending on clinical indication.

1 hospitalization visit (in-person)

Post-operative Follow-up

Duration - Up to 6 months after treatment

Participants are monitored for pain relief, wound healing complications, and tumor control at discharge and at 3 and 6 months after treatment.

3 visits (in-person) at discharge, 3 months, and 6 months after treatment

Trial Site Locations

Total: 1 location

1

University Medical Center Goettingen

Göttingen, Germany, 37073

Actively Recruiting

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Research Team

C

Carla Marie Zwerenz, Dr. med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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