Clinical trial NCT06116019: Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Head and Neck Cancer
NSCLC
SCLC
Esophageal Cancer
Bladder Cancer
Rectum Cancer
Cervix Cancer
Other Carcinoma
Keywords: online adaptive radiation therapy
ART
cone beam CT
ePROMS
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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).


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

Primary outcomes:
measure: Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
timeFrame: Throughout the treatment period, up to 6 weeks.
Secondary outcomes:
measure: Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities
timeFrame: Throughout the treatment period, up to 6 weeks.
measure: Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities
timeFrame: Throughout the treatment period, up to 6 weeks.
measure: 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
timeFrame: Throughout the treatment period, up to 6 weeks.
measure: Patient Reported Toxicity
timeFrame: 2 years
measure: Physician Reproted Toxicity
timeFrame: 2 years
measure: Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30
timeFrame: 2 years
measure: Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F
timeFrame: 2 years
measure: Local Control
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin
Study officials:
References: