Off-line Adaptive Proton Therapy

NCT07866547 — Not yet recruiting, 100 participants, University Medical Center Groningen

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Registry	NCT07866547, acronym o-APT
Status	Not yet recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	University Medical Center Groningen (Other)
Conditions	Oropharyngeal Carcinoma
Interventions	Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation (Other)
Dates	start 2026-10-01 (estimated), primary completion 2027-07-31 (estimated), completion 2027-07-31 (estimated), first posted 2026-10-08, last updated 2026-10-08
Locations	1 site in Netherlands

-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 modifications more efficiently than current clinical practice, without affecting patient care.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Oropharyngeal Cancer Patients Receiving Proton Therapy		Other: Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation	Patients with oropharyngeal cancer treated with proton therapy

Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation (Other): Evaluation of an off-line adaptive proton therapy workflow using routinely collected clinical data

+Outcome measures

Primary outcomes

Dose Adjustments Ready to Use Before the Next Fraction [From the first to the last radiotherapy fraction, approximately 7 weeks.]: Availability of adapted treatment plans before the next treatment fraction

Secondary outcomes

Accuracy of early identification of the need for treatment plan adaptation [From the first to the last radiotherapy fraction, approximately 7 weeks.]: 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.

+Eligibility

Sex: All, ages: 16 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* None

+Locations (1)

Facility	City	Country	Status
University Medical Center Groningen	Groningen, Provincie Groningen	Netherlands