Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

Study Overview
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Brief Summary
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The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian/SHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).

Official Title
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A Prospective Study on Online Adaptive Radiotherapy (ART) Using the ETHOS Linear Accelerator for Various Tumor Entities and the Feasibility of Integrating Multi-Parametric Patient Data Into the Adaptive Workflow

Conditions
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Prostate Cancer, Head and Neck Cancer, NSCLC, SCLC, Esophageal Cancer, Bladder Cancer, Rectum Cancer, Cervix Cancer, Other Carcinoma

Intervention / Treatment
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* Radiation: Online adaptive radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 years) All tumor entities with an indication for radiotherapy and/or chemoradiotherapy Signed informed consent Exclusion Criteria: Pregnancy Patients who are not capable of giving consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Online adaptive radiation therapy|Daily cone-beam CT based online adaptive radiation therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities | This measure evaluates the success rate of adaptive radiotherapy sessions with ETHOS across different tumor types. It measures the total count of adaptive treatment sessions that were completed without interruption or complication for each patient. | Throughout the treatment period, up to 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities | This measure quantifies the adaptive treatment sessions for which a dosimetric advantage for target coverage is detected in patients undergoing adaptive radiotherapy across different tumor types. | Throughout the treatment period, up to 6 weeks. | 
| Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities | This measure quantifies the adaptive treatment sessions for which a dosimetric advantage for organs at risk is detected in patients undergoing adaptive radiotherapy across different tumor types. | Throughout the treatment period, up to 6 weeks. | 
| Number of Adaptive Radiotherapy Sessions with Dosimetric Benefit to Organs at Risk Following ePROMs and ePRT-based Plan Adjustments in Patients with Various Tumor Entities | This measure quantifies the adaptive treatment sessions for which in silico analysis identifies a potential dosimetric advantage to organs at risk following ePROMs and ePRT-based plan adjustments. | Throughout the treatment period, up to 6 weeks. | 
| Patient Reported Toxicity | Frequency and severity of treatment-related toxicities in patients as scored using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) | 2 years | 
| Physician Reproted Toxicity | Frequency and severity of treatment-related toxicities in patients as scored using the the Common Terminology Criteria for Adverse Events (CTCAE) | 2 years | 
| Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30 | This measure evaluates the quality of life of patients undergoing adaptive radiotherapy using the EORTC QLQ-C30 scale. | 2 years | 
| Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F | This measure quantifies the fatigue experienced by patients undergoing adaptive radiotherapy as determined by the FACIT-F scale. | 2 years | 
| Local Control | Freedom from local progression after adaptive radiotherapy | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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online adaptive radiation therapy, ART, cone beam CT, ePROMS