Real-time Motion Management During Prostate and Lung Radiotherapy

Trial Title: Real-time Motion Management During Prostate and Lung Radiotherapy

NCT ID: NCT05844761

Condition: Cancer of Lung
Lung Metastasis
Cancer of Prostate

Conditions: Official terms:
Prostatic Neoplasms
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Triggered imaging on TrueBeam with margin reduction
Description: At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.
Arm group label: Triggered Imaging with TrueBeam for prostate cancer

Intervention type: Radiation
Intervention name: Synchrony MLC tracking on fiducials with margin reduction
Description: At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
Arm group label: Synchrony with Radixact for prostate cancer

Intervention type: Radiation
Intervention name: Synchrony MLC tracking and lung adaptive model with margin reduction
Description: 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.
Arm group label: Synchrony with Radixact for lung cancer

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.

Detailed description: This study will assess the feasibility of implementing real-time tracking in a clinical setting to account for the relative motion of the moving tumours localised to the prostate or lung. The capability to track the treatment target's motion will ensure that the dose prescribed by the radiation oncologist is the dose delivered to the target and minimises side effects to the critical organs. During radiation treatment, the target position will be monitored in real-time using built-in imaging technology. The radiation beam shape will be altered to compensate for the moved target positions by the treatment delivery system. The delivered dose to the patient will be calculated after the treatment and compared to the dose without real-time tracking to assess the potential benefit to treatment efficacy, recognising that the radiation dose received by tumour tissue is a very strong biomarker for response. The estimated dose distributions will be compared to the original plan for non-inferiority using the dose reconstruction method based on the prostate motion trajectory and the logged MLC positions (beam shapes). Also, the impact on organs at risk doses due to MLC target tracking.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 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 Exclusion Criteria: 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Skåne University Hospital

Address:
City: Lund
Zip: 21185
Country: Sweden

Start date: May 1, 2023

Completion date: December 2025

Lead sponsor:
Agency: Region Skane
Agency class: Other

Source: Region Skane

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05844761