Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online adaptive radiation therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Head and Neck Cancer, NSCLC, SCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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).
Interventions
- Radiation Online adaptive radiation therapy
Daily cone-beam CT based online adaptive radiation therapy
Primary outcome measures
- Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities [Time frame: Throughout the treatment period, up to 6 weeks.]
Secondary outcome measures (8)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities [Time frame: 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 [Time frame: 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 [Time frame: Throughout the treatment period, up to 6 weeks.]
- Patient Reported Toxicity [Time frame: 2 years]
- Physician Reproted Toxicity [Time frame: 2 years]
- Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30 [Time frame: 2 years]
- Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F [Time frame: 2 years]
- Local Control [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité - Universitätsmedizin — Berlin
Identifiers
NCT: NCT06116019 · 3000902