Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

Recruiting

• Conditions: Head and Neck Cancer; NSCLC; SCLC; Cervix Cancer; Prostate Cancer; Other Carcinoma; Bladder Cancer; Esophageal Cancer; Rectum Cancer

• Registration Number: NCT06116019
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Status Verified: 2023-10
• Study Start: 2023-10-11
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2026-10-09
• Study Completion: 2027-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 649

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities	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 Outcome Measures

Name	Time	Method
Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30	2 years	This measure evaluates the quality of life of patients undergoing adaptive radiotherapy using the EORTC QLQ-C30 scale.
Local Control	2 years	Freedom from local progression after adaptive radiotherapy
Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F	2 years	This measure quantifies the fatigue experienced by patients undergoing adaptive radiotherapy as determined by the FACIT-F scale.
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.	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.
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.	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.
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.	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.
Patient Reported Toxicity	2 years	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)
Physician Reproted Toxicity	2 years	Frequency and severity of treatment-related toxicities in patients as scored using the the Common Terminology Criteria for Adverse Events (CTCAE)

Trial Locations

Locations (1)

Charité - Universitätsmedizin; 🇩🇪 Berlin, Germany