Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

Prostate Cancer Clinical Trial

— ART-02  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116019
• Other study ID #: 3000902
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: October 9, 2027

Study information

• Verified date: October 2023
• Source: Charite University, Berlin, Germany
• Contact: Goda Kalinauskaite, MD
• Phone: +49 30 450 527318
• Email: goda.kalinauskaite[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 649
• Est. completion date: October 9, 2027
• Est. primary completion date: October 9, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Cervix Cancer
• Esophageal Cancer
• Head and Neck Cancer
• NSCLC
• Prostate Cancer
• Rectal Neoplasms
• Rectum Cancer
• SCLC
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Online adaptive radiation therapy
Daily cone-beam CT based online adaptive radiation therapy

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Local Control	Freedom from local progression after adaptive radiotherapy	2 years