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Stereotactic Body Radiotherapy Followed by Surgical Stabilization in Spinal Metastases

NCT05060653 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-18

No results posted yet for this study

Summary

The aim of this study is to assess pain response after combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.

Conditions

  • Spinal Neoplasms
  • Neoplasm Metastasis
  • Radiosurgery
  • Surgery

Interventions

OTHER

SBRT followed by surgical stabilization within 24-48 hours

In a first step, patients will undergo SBRT with active sparing of the surgical site. Patients will receive high dose, single to few fractions radiotherapy consisting of a boost to the metastases exclusively. The bony compartment containing the metastatic lesion will receive an elective dose in order to treat subclinical disease. Treatment planning is performed on the pre-treatment CT and MRI data in radiotherapy position that are mutually registered to yield information on all relevant structures for planning. Dose constraints are set for the organ at risks based on institution specific guidelines. All patients will be treated with on online position verification protocol based on institution specific guidelines. Hereafter, surgical intervention will be performed to the standard of care.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Jorrit-Jan Verlaan, MD, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-10-31
Completion
2023-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060653 on ClinicalTrials.gov