Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)

Not Applicable

• Conditions: Solid Tumor, Adult
• Interventions: Other: Setup and Imaging for at CT radiation planning

• Registration Number: NCT05252975
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).

Detailed Description

This is a prospective, non-randomised radiotherapy planning study.

Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.

Patients continue to receive treatment in the proposed position as recommended y their treating physician.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• • Patients undergoing Cyberknife treatment to spinal metastasis

  • >18 years of age
  • Thoracic, lumbar and sacral spinal metastasis
  • Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability).
  • All solid tumour types will be eligible

Exclusion Criteria

• • Primary spinal tumours

  • Vertebral disease resulting in unstable spinal vertebrae
  • Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position).
  • Patients with significant pain on prone lying (to be assessed by physician prior to consent)
  • Bilsky epidural score of 2 or greater (see appendix 1)
  • Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone	Setup and Imaging for at CT radiation planning	Patients undergo prone setup and imaging for radiation planning
Supine	Setup and Imaging for at CT radiation planning	Patients undergo supine setup and imaging for radiation planning

Primary Outcome Measures

Name	Time	Method
PTV isodose coverage	Through study completion, an average of 1 year.	To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions

Secondary Outcome Measures

Name	Time	Method
Comfort scores	Immediate	Evaluate comfort scores in both treatment positions (supine and prone)
Organs at risk dose	Immediate	Compare organs at risk dose between supine and prone positioning.
CT and MRI registration	Immediate	Evaluate CT and MRI registration on tumour target delineation
Treatment time duration	Immediate	Treatment time duration

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom