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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:
Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric accuracy | The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape based on the centroid of the shape as assessed with mean absolute error (MAE) | At treatment completion, approximately 1-4 weeks |
| Motion trajectory |
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Inclusion Criteria:
For prostate cancer patients:
For lung cancer patients:
Exclusion Criteria:
For prostate cancer patients:
For lung cancer patients:
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| Name | Affiliation | Role |
|---|---|---|
| André Haraldsson, PhD, MPE | Skane university hospital, Lund university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Lund | Skåne County | 21185 | Sweden |
The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with European Union legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.
<1y after study. At least 5 years
On request and as supplementary at publication
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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.
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| 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. |
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| 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. |
|
Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE. |
| At treatment completion, approximately 1-4 weeks |
| Acute Toxicity | EORTC guided and physician assessed | Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction.. |
| Mechanical & software failure | The percentage of fractions delivered without software or mechanical failure | At treatment completion, approximately 1-4 weeks |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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