Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>18 years)

All tumor entities with an indication for radiotherapy and/or chemoradiotherapy

Signed informed consent

Disqualifiers

Pregnancy

Patients who are not capable of giving consent

Trial population

Patients older than 18 years, diagnosed with malignancies that have an indication for radiation therapy, with or without concurrent chemotherapy, and who are receiving online adaptive radiation therapy at the Department of Radiation Oncology at Charité.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Online adaptive radiation therapy

    Radiation

    Daily cone-beam CT based online adaptive radiation therapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Throughout the treatment period, up to 6 weeks.

Secondary outcomes

1

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.

Time frame
Throughout the treatment period, up to 6 weeks.
2

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.

Time frame
Throughout the treatment period, up to 6 weeks.
3

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.

Time frame
Throughout the treatment period, up to 6 weeks.
4

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)

Time frame
2 years

Other outcomes

Sponsors and contacts

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