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

NCT ID: NCT05252975

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-04-01

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supine

Patients undergo supine setup and imaging for radiation planning

Group Type: ACTIVE_COMPARATOR

Setup and Imaging for at CT radiation planning

Intervention Type: OTHER

Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.

Prone

Patients undergo prone setup and imaging for radiation planning

Group Type: EXPERIMENTAL

Setup and Imaging for at CT radiation planning

Intervention Type: OTHER

Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.

Interventions

Setup and Imaging for at CT radiation planning

Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Merina Ahmed

Role: CONTACT

merina.ahmed@rmh.nhs.uk

02086426011

Facility Contacts

Bianca Peet

Role: primary

bianca.peet@rmh.nhs.uk

02086613566

Other Identifiers

CCR 5216

Identifier Type: -

Identifier Source: org_study_id