Real-time Motion Management During Prostate and Lung Radiotherapy

NCT05844761 | Enrolling By Invitation

• 1 other identifier: 2022-05273-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are:

• What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management
• What are the dosimetric and geometrical accuracy to patient for the motion management techniques. Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.

Conditions

Cancer of Lung; Lung Metastasis; Cancer of Prostate

Outcome Measures

Primary Outcomes (1)

• Dosemetric accuracy

  Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.

  At treatment completion, approximately 1-4 weeks

Secondary Outcomes (4)

• Geometric accuracy

  At treatment completion, approximately 1-4 weeks

• Motion trajectory

  At treatment completion, approximately 1-4 weeks

• Acute Toxicity

  Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..

• Mechanical & software failure

  At treatment completion, approximately 1-4 weeks

Study Arms (3)

Triggered Imaging with TrueBeam for prostate cancer

EXPERIMENTAL

Patients will undergo radiotherapy using the Triggered Imaging technique with TrueBeam for prostate cancer. The technology on the TrueBeam allows for monitoring and gating of the radiation beam in relation to the target position.

Radiation: Triggered imaging on TrueBeam with margin reduction

Synchrony with Radixact for prostate cancer

EXPERIMENTAL

Patients will undergo radiotherapy using the Synchrony technique with Radixact for prostate cancer. Multi-Leaf Collimator Adaptation (MLC) and kilovoltage (kV) Intrafraction Monitoring with the Synchrony technique on the Radixact radiotherapy machine.

Radiation: Synchrony MLC tracking on fiducials with margin reduction

Synchrony with Radixact for lung cancer

EXPERIMENTAL

Patients will undergo radiotherapy using the Synchrony technique with Radixact for lung cancer. MLC Adaptation, Respiratory Motion Tracking, and kV Intrafraction Monitoring with the adaptive Synchrony technique on the Radixact radiotherapy machine.

Radiation: Synchrony MLC tracking and lung adaptive model with margin reduction

Interventions

Triggered imaging on TrueBeam with margin reduction RADIATION

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.

Triggered Imaging with TrueBeam for prostate cancer

Synchrony MLC tracking on fiducials with margin reduction RADIATION

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.

Synchrony with Radixact for prostate cancer

Synchrony MLC tracking and lung adaptive model with margin reduction RADIATION

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique for lung cancer.

Synchrony with Radixact for lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For prostate cancer patients:
• Patients histologically proven prostate adenocarcinoma
• Prostate specific antigen (PSA) obtained within three months prior to enrollment
• Localised prostate cancer at any stage eligible for radiotherapy: i.e. any T- or Gleason stage, but no pelvic lymph nodes can be included within the target to be treated
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Ability to understand and the willingness to sign a written informed consent document.
• Hypofractionated radiation therapy (HYPO) fractionated patients with a prescribed dose of 42.7Gy in 7 fractions.
• MRIOnly workflow meaning synthetic generated CT based on Magnetic resonance imaging (MRI)
• Patients over 40 years old
• For lung cancer patients:
• Lung cancer or localised metastatic disease from other cancer diagnoses, accepted for stereotactic radiotherapy to 45Gy in 3 fractions
• Lesion distinguishable on Computer Tomography and where the majority of adjacent tissue is the lung.
• Ability to understand and the willingness to sign a written informed consent document.
• Is able to perform treatment simulation

You may not qualify if:

• For prostate cancer patients:
• Patient must have three gold fiducial markers inserted in the prostate
• Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
• Patients with overlapping implanted gold fiducials in X-ray imaging
• Unfeasible to track fiducials with kv imaging/existing online imaging systems
• For lung cancer patients:
• Previous treatment with radiotherapy for lung cancer or lung metastasis
• Idiopathic lung fibrosis

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 21185, Sweden

Location

MeSH Terms

Conditions

Lung Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• André Haraldsson, PhD, MPE

  Skane university hospital, Lund university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will undergo radiotherapy using motion management techniques: Triggered Imaging with TrueBeam for prostate cancer, Synchrony with Radixact for prostate cancer, and Synchrony with Radixact for lung cancer. Dosimetric coverage will be assessed after treatment based on the accuracy of the motion management techniques and compared with dose coverage without motion management. After interim analysis, Planning target volume (PTV) will be reduced based on dosimetric accuracy in each arm.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: \<1y after study. At least 5 years
• Access Criteria: On request and as supplementary at publication

Locations

SE (1)