[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655841":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":26,"armGroups":31,"interventions":38,"overallOfficials":26,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":72,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation between ΔNTCP_expected and ΔNTCP_delivered.","The correlation between ΔNTCP\\_expected and ΔNTCP\\_delivered, is an investigation to see whether the ΔNTCP (ΔNTCP\\_expected) calculated from the planning CT from the refering center, correlates with the ΔNTCP from the actual delivered plan (ΔNTCP\\_delivered) at the Danish Centre for Particle Therapy.","From enrollment to end of radiotherapy, average 5 weeks.",[14],{"measure":15,"description":16,"timeFrame":17},"Incidence of acute, late toxicity and other events","A) Acute toxicity\n\n1. Radiation dermatitis\n2. Cough\n3. Fatigue\n4. Dysphagia\n\nAdd a 2nd Outcome Measure\n\nB) Incidence of:\n\n1. secondary cancers (breast and lung)\n2. other secondary cancers within the radiation field.\n3. Myocardial infarction\n4. Other cardiac events\n\nAdd a 3rd Outcome Measure C) Overall survival\n\nAdd a 4th Outcome Measure D) Recurrence free survival","From enrollment to 20 years after end of radiation",[19],{"measure":20,"description":21,"timeFrame":22},"Radiation dosimetry","Data from the study will be compared between\n\n1\\) Patients treated with protons vs patients treated with photons. 2) Data from the study compared to Historical data. 3) NTCP estimated risk vs. actual events (protons and photons).","From enrollment to 20 years after end of radiotherapy",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":26},"NONE","Patients are referred for proton therapy based on a reduction of risk of late toxicity which is established on consensus guidelines and multidisciplinary discussions in a study panel\u002Fconsensus conference. However, this reduction is calculated based on the referring center's treatment planning scan and patient setup.\n\nThe aim of this national study is to investigate whether the calculated reduction of risk of toxicity with proton therapy at the referring centers differs from the actual delivered plan at DCPT (ΔNTCP in delivered proton therapy plan versus reference photon plan from referring center).\n\nThe study also aims to investigate effect and side effects of proton and photon radiotherapy, including a systematically prospective registration of acute and late side effects and to evaluate the use of a model-based approach to select patients for proton therapy.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Proton","EXPERIMENTAL","Patients will receive proton therapy based on selection criteria",[37],"Radiation: Proton therapy",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":26},"RADIATION","Proton therapy","If selected, patients will recieve protontherapy instead of photon therapy",[33],[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Mogens Bernsdorf, Md. Phd","CONTACT","+4535459681","mogens.bernsdorf@regionh.dk",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Dept. of oncology","RECRUITING","Copenhagen","Select A State","2100","Denmark","DK",{"type":60,"coordinates":61},"Point",[62,63],12.56553,55.67594,{"lat":63,"lon":62},[66],{"name":67,"role":47,"phone":48,"phoneExt":26,"email":49},"Mogens Bernsdorf, Md. PhD.",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mogens Bernsdorf","MD, PhD",[73,76,78],{"name":74,"class":75},"Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark","UNKNOWN",{"name":77,"class":6},"Aalborg University Hospital",{"name":79,"class":6},"Odense University Hospital","100655841","proton-therapy-for-mediastinal-lymphoma-promly-100655841",false,"NCT07817641","Proton Therapy for Mediastinal Lymphoma (PROMLY)","PROMLY","Inclusion Criteria:\n\n* Patients 18 years or older\n* Histologically proven Hodgkin or non-Hodgkin lymphoma\n* Disease constrained within the mediastinum +\u002F- neck and\u002For axilla involvement.\n* Candidates for curative intended treatment\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior radiotherapy to the thorax\n* Other current malignancy\n* Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.","ALL","18 Years",{"count":90,"type":91},139,"ESTIMATED","INTERVENTIONAL",[24],"The study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy.",[96,97,98],"Mediastinal Lymphoma","Hodgkin Disease Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)",[100,101,102,103,104,105],"proton therapy","mediastinal lymphoma","NTCP","normal tissue complication probability","Hodgkin Lymphoma","Lymphoma","2026-09-10",{"date":108,"type":109},"2026-09-14","ACTUAL",{"date":111,"type":109},"2026-05-01",{"date":113,"type":91},"2046-05-01",{"name":5,"class":6},1]