Oropharyngeal Carcinomao-APTNCT07866547
Off-line Adaptive Proton Therapy
An observational study of Oropharyngeal Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This prospective in-silico study evaluates a novel Off-line Adaptive Proton Therapy (o-APT) workflow for patients with oropharyngeal cancer receiving proton therapy. The study assesses whether automated image analysis, treatment plan adaptation, and quality assurance can identify and prepare treatment plan… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Oropharyngeal Carcinoma
- What is being tested?
- Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 31 Jul 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with oropharyngeal cancer receiving curatively intended proton therapy at the University Medical Center Groningen (UMCG)
Who may be able to join
- Oropharyngeal cancer patients
- Planned for curatively intended proton therapy
- Treated with definitive radiotherapy, chemoradiation, or bioradiation
- Provided informed consent according to Standard Follow-up Program (SFP) for using data for research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Pietro Pisciotta, +31655256888, p.pisciotta@umcg.nl
About this study
This prospective in-silico study evaluates a novel Off-line Adaptive Proton Therapy (o-APT) workflow for patients with oropharyngeal cancer receiving proton therapy. The study assesses whether automated image analysis, treatment plan adaptation, and quality assurance can identify and prepare treatment plan modifications more efficiently than current clinical practice, without affecting patient care.
Read the detailed description
Proton therapy is highly sensitive to anatomical and positioning changes that may occur during treatment. Current methods for identifying the need for treatment plan adaptation rely on periodic verification imaging and manual review processes, which can delay implementation of adapted treatment plans.
This study evaluates an Off-line Adaptive Proton Therapy (o-APT) workflow designed to support earlier identification of clinically relevant anatomical changes and more efficient treatment plan adaptation. The workflow combines artificial intelligence-based generation of synthetic computed tomography (CT) images from routine cone-beam computed tomography (CBCT) scans, automated treatment plan generation, and automated quality assurance procedures.
The study is conducted using data collected during routine clinical care. The investigational workflow is evaluated in parallel with standard clinical practice and does not influence treatment decisions or patient care. The aim is to assess the feasibility of integrating this workflow into the proton therapy adaptation process and to evaluate its potential to improve the efficiency and timeliness of treatment plan adaptation.
- Conditions
- Oropharyngeal Carcinoma
- Being tested
- Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation
- Keywords
- head and neck cancer, proton therapy, adaptive radiotherapy
- Medical subject headings
- Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-line Adaptive Proton Therapy (o-APT) Workflow EvaluationOther
Evaluation of an off-line adaptive proton therapy workflow using routinely collected clinical data
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal Cancer Patients Receiving Proton Therapy | Patients with oropharyngeal cancer treated with proton therapy Receives: Other: Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Adjustments Ready to Use Before the Next Fraction
Availability of adapted treatment plans before the next treatment fraction
Measured: From the first to the last radiotherapy fraction, approximately 7 weeks.
Secondary outcomes (1)
Accuracy of early identification of the need for treatment plan adaptation
Accuracy of the o-APT workflow in identifying the need for treatment plan adaptation, with particular focus on positive predictive value and negative predictive value.
Measured: From the first to the last radiotherapy fraction, approximately 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866547
- Sponsor's protocol ID
- 2024/554
- Acronym
- o-APT
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan has been made to make individual participant data available to external researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-line Adaptive Proton Therapy
- ClinicalTrials.gov ID
- NCT07866547
- Acronym / sponsor ID
- o-APT / 2024/554
- Conditions
- Oropharyngeal Carcinoma
- Keywords
- head and neck cancer, proton therapy, adaptive radiotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Oct 2026 (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.
This prospective in-silico study evaluates a novel Off-line Adaptive Proton Therapy (o-APT) workflow for patients with oropharyngeal cancer receiving proton therapy. The study assesses whether automated image analysis, treatment plan adaptation, and quality assurance can identify and prepare treatment plan modifications more efficiently than current clinical practice, without affecting patient care.
Detailed description
Proton therapy is highly sensitive to anatomical and positioning changes that may occur during treatment. Current methods for identifying the need for treatment plan adaptation rely on periodic verification imaging and manual review processes, which can delay implementation of adapted treatment plans.
This study evaluates an Off-line Adaptive Proton Therapy (o-APT) workflow designed to support earlier identification of clinically relevant anatomical changes and more efficient treatment plan adaptation. The workflow combines artificial intelligence-based generation of synthetic computed tomography (CT) images from routine cone-beam computed tomography (CBCT) scans, automated treatment plan generation, and automated quality assurance procedures.
The study is conducted using data collected during routine clinical care. The investigational workflow is evaluated in parallel with standard clinical practice and does not influence treatment decisions or patient care. The aim is to assess the feasibility of integrating this workflow into the proton therapy adaptation process and to evaluate its potential to improve the efficiency and timeliness of treatment plan adaptation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal Cancer Patients Receiving Proton Therapy | – | Other: Off-line Adaptive Proton Therapy (o-APT) Workflow EvaluationPatients with oropharyngeal cancer treated with proton therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with oropharyngeal cancer receiving curatively intended proton therapy at the University Medical Center Groningen (UMCG)
Key inclusion criteria (4 listed)
- Oropharyngeal cancer patients
- Planned for curatively intended proton therapy
- Treated with definitive radiotherapy, chemoradiation, or bioradiation
- Provided informed consent according to Standard Follow-up Program (SFP) for using data for research
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Off-line Adaptive Proton Therapy (o-APT) Workflow EvaluationEvaluation of an off-line adaptive proton therapy workflow using routinely collected clinical data | Other | Oropharyngeal Cancer Patients Receiving Proton Therapy |
Primary outcome
Dose Adjustments Ready to Use Before the Next Fraction
Time frame: From the first to the last radiotherapy fraction, approximately 7 weeks.
Availability of adapted treatment plans before the next treatment fraction
1 secondary outcome
Accuracy of early identification of the need for treatment plan adaptation
Time frame: From the first to the last radiotherapy fraction, approximately 7 weeks.
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 8 Oct 2026.
- Individual participant dataSharing planned: No. No plan has been made to make individual participant data available to external researchers
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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 Oropharyngeal Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Netherlands. 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 Pietro Pisciotta (+31655256888, p.pisciotta@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Adjustments Ready to Use Before the Next Fraction (time frame: From the first to the last radiotherapy fraction, approximately 7 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 8 Oct 2026.