Prostate CancerART-02NCT06116019
Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
An observational study of Prostate Cancer and Head and Neck Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Head and Neck Cancer, NSCLC
- What is being tested?
- Online adaptive radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 649 participants
- Where
- 1 siteGermany
- Study dates
- 11 Oct 2023to 9 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adult patients (>18 years)
- All tumor entities with an indication for radiotherapy and/or chemoradiotherapy
- Signed informed consent
Who cannot join
- Pregnancy
- Patients who are not capable of giving consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin
Berlin
Goda Kalinauskaite, goda.kalinauskaite@charite.de
About this study
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
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).
- Conditions
- Prostate Cancer, Head and Neck Cancer, NSCLC, SCLC, Esophageal Cancer, Bladder Cancer
- Being tested
- Online adaptive radiation therapy
- Keywords
- online adaptive radiation therapy, ART, cone beam CT, ePROMS
- Medical subject headings
- Prostatic Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms, Urinary Bladder Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online adaptive radiation therapyRadiation
Daily cone-beam CT based online adaptive radiation therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the treatment period, up to 6 weeks.
Secondary outcomes (8)
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.
Measured: Throughout the treatment period, up to 6 weeks.
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.
Measured: Throughout the treatment period, up to 6 weeks.
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.
Measured: Throughout the treatment period, up to 6 weeks.
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)
Measured: 2 years
Physician Reproted Toxicity
Frequency and severity of treatment-related toxicities in patients as scored using the the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Local Control
Freedom from local progression after adaptive radiotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start11 Oct 2023
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 649 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goda Kalinauskaite, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116019
- Sponsor's protocol ID
- 3000902
- Acronym
- ART-02
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116019
- Acronym / sponsor ID
- ART-02 / 3000902
- Conditions
- Prostate Cancer, Head and Neck Cancer, NSCLC, SCLC, Esophageal Cancer, Bladder Cancer
- Keywords
- online adaptive radiation therapy, ART, cone beam CT, ePROMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 649 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Oct 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients (>18 years)
- All tumor entities with an indication for radiotherapy and/or chemoradiotherapy
- Signed informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Patients who are not capable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online adaptive radiation therapyDaily cone-beam CT based online adaptive radiation therapy | Radiation | – |
Primary outcome
Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
Time frame: 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.
8 secondary outcomes
Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities
Time frame: Throughout the treatment period, up to 6 weeks.
Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities
Time frame: Throughout the treatment period, up to 6 weeks.
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
Time frame: Throughout the treatment period, up to 6 weeks.
Patient Reported Toxicity
Time frame: 2 years
Physician Reproted Toxicity
Time frame: 2 years
Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30
Time frame: 2 years
Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F
Time frame: 2 years
Local Control
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Head and Neck Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goda Kalinauskaite, MD (+49 30 450 527318, goda.kalinauskaite@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities (time frame: Throughout the treatment period, up to 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.