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Trial Title:
Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
NCT ID:
NCT06116019
Condition:
Prostate Cancer
Head and Neck Cancer
NSCLC
SCLC
Esophageal Cancer
Bladder Cancer
Rectum Cancer
Cervix Cancer
Other Carcinoma
Conditions: Official terms:
Uterine Cervical Neoplasms
Rectal Neoplasms
Conditions: Keywords:
online adaptive radiation therapy
ART
cone beam CT
ePROMS
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Online adaptive radiation therapy
Description:
Daily cone-beam CT based online adaptive radiation therapy
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).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Charité - Universitätsmedizin
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Goda Kalinauskaite
Email:
goda.kalinauskaite@charite.de
Start date:
October 11, 2023
Completion date:
October 9, 2027
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116019
