[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659435":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":29,"overallOfficials":17,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":17,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":17,"enrollmentInfo":66,"targetDuration":17,"studyType":69,"phases":17,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":17,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Dose Adjustments Ready to Use Before the Next Fraction","Availability of adapted treatment plans before the next treatment fraction","From the first to the last radiotherapy fraction, approximately 7 weeks.",[14],{"measure":15,"description":16,"timeFrame":12},"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.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","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.\n\nThis 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.\n\nThe 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.","Patients with oropharyngeal cancer receiving curatively intended proton therapy at the University Medical Center Groningen (UMCG)",[24],{"label":25,"type":17,"description":26,"interventionNames":27},"Oropharyngeal Cancer Patients Receiving Proton Therapy","Patients with oropharyngeal cancer treated with proton therapy",[28],"Other: Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation",[30],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":17},"Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation","Evaluation of an off-line adaptive proton therapy workflow using routinely collected clinical data",[25],[35],{"name":36,"role":37,"phone":38,"phoneExt":17,"email":39},"Pietro Pisciotta","CONTACT","+31655256888","p.pisciotta@umcg.nl",[41],{"facility":5,"status":17,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Groningen","Provincie Groningen","9713 GZ","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],6.56667,53.21917,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":38,"phoneExt":17,"email":39},{"type":56,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100659435","off-line-adaptive-proton-therapy-100659435",false,"NCT07866547","Off-line Adaptive Proton Therapy","o-APT","Inclusion Criteria:\n\n* Oropharyngeal cancer patients\n* Planned for curatively intended proton therapy\n* Treated with definitive radiotherapy, chemoradiation, or bioradiation\n* Provided informed consent according to Standard Follow-up Program (SFP) for using data for research\n\nExclusion Criteria:\n\n* None","ALL","16 Years",{"count":67,"type":68},100,"ESTIMATED","OBSERVATIONAL","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.",[72],"Oropharyngeal Carcinoma",[74,75,76],"head and neck cancer","proton therapy","adaptive radiotherapy","NOT_YET_RECRUITING","2026-10-05",{"date":80,"type":81},"2026-10-08","ACTUAL",{"date":83,"type":68},"2026-10-01",{"date":85,"type":68},"2027-07-31",{"name":5,"class":6},1]