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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 649
- Locations
- 1
- Primary Endpoint
- Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Goda Kalinauskaite
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
Time Frame: Throughout the treatment period, up to 6 weeks.
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.
Secondary Outcomes
- Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30(2 years)
- Local Control(2 years)
- Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F(2 years)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities(Throughout the treatment period, up to 6 weeks.)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities(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(Throughout the treatment period, up to 6 weeks.)
- Patient Reported Toxicity(2 years)
- Physician Reproted Toxicity(2 years)