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Not yet recruitingNCT07866547o-APTUpdated Oct 8, 2026

Off-line Adaptive Proton Therapy

An observational study in Oropharyngeal Carcinoma, sponsored by University Medical Center Groningen. Not yet recruiting at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University Medical Center Groningen · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Oropharyngeal Carcinoma

Keywords

  • head and neck cancer
  • proton therapy
  • adaptive radiotherapy
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In context

Oropharyngeal Neoplasms

373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.

This study's planned enrollment of 100 is close to the median of 111 across 66 observational studies indexed under Oropharyngeal Neoplasms.

Browse Oropharyngeal Neoplasms studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 610 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with oropharyngeal cancer receiving curatively intended proton therapy at the University Medical Center Groningen (UMCG)

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Oropharyngeal Cancer Patients Receiving Proton Therapy

    Patients with oropharyngeal cancer treated with proton therapy

    Other: Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation

Interventions

  • OtherOff-line Adaptive Proton Therapy (o-APT) Workflow Evaluation

    Evaluation of an off-line adaptive proton therapy workflow using routinely collected clinical data

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What researchers measure

Primary outcomes

  1. Dose Adjustments Ready to Use Before the Next Fraction

    Availability of adapted treatment plans before the next treatment fraction

    Time frame: 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.

    Time frame: From the first to the last radiotherapy fraction, approximately 7 weeks.

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, Provincie Groningen 9713 GZ, Netherlands
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References and documents

Individual participant data

Plan to share: No — No plan has been made to make individual participant data available to external researchers

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07866547
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Pietro Pisciotta
Contact
p.pisciotta@umcg.nl
+31655256888

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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