[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583997":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":47,"interventions":54,"overallOfficials":60,"centralContacts":64,"locations":73,"responsibleParty":150,"collaborators":153,"id":168,"slug":39,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":169,"sex":175,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":39,"studyType":181,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":76,"whyStopped":39,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Uppsala University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Progression free survival (PFS)","Time from study entry until disease progression or death from any cause.","Outcome will be measured after 1, 3, 5 and 16 years.",[14,17,20,24,27,31,34,37],{"measure":15,"description":16,"timeFrame":12},"Overall survival (OS)","Time from diagnostic biopsy until death from any cause.",{"measure":18,"description":19,"timeFrame":12},"Time to progression (TTP)","Time from diagnostic biopsy until objective tumor progression, not includingdeath.",{"measure":21,"description":22,"timeFrame":23},"Absorbed dose to organs at risk.","Will be collected from Dose Volume Histograms.","Outcome will be measured at baseline.",{"measure":25,"description":26,"timeFrame":12},"Patterns of failure.","Are failures located within or outside of the radiation field?",{"measure":28,"description":29,"timeFrame":30},"Acute adverse events.","The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.","Outcome will be measured within 3 months.",{"measure":32,"description":33,"timeFrame":12},"Long-term adverse events.","This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.",{"measure":35,"description":36,"timeFrame":12},"Quality of life.","EORTC quality of life questionnaire (QLQ)-C30.",{"measure":35,"description":38,"timeFrame":12},"EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"NA","SINGLE_GROUP","Proton therapy, non-inferiority compared to historical cohort.","TREATMENT",{"masking":46,"maskingDescription":39,"whoMasked":39},"NONE",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Proton therapy","EXPERIMENTAL","Stage 1-2A Hodgkin Lymphoma.",[53],"Radiation: Proton therapy.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":39},"RADIATION","Proton therapy.","Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).",[49],[61],{"name":62,"affiliation":5,"role":63},"Daniel Molin, MD, PhD","PRINCIPAL_INVESTIGATOR",[65,69],{"name":62,"role":66,"phone":67,"phoneExt":39,"email":68},"CONTACT","+46186110000","daniel.molin@igp.uu.se",{"name":70,"role":66,"phone":71,"phoneExt":39,"email":72},"Christina Goldkuhl, MD","+46313421000","christina.goldkuhl@vgregion.se",[74,89,101,113,128,140],{"facility":75,"status":76,"city":77,"state":39,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Sahlgrenska University Hospital","RECRUITING","Gothenburg","S-41345","Sweden","SE",{"type":82,"coordinates":83},"Point",[84,85],11.96679,57.70716,{"lat":85,"lon":84},[88],{"name":70,"role":66,"phone":39,"phoneExt":39,"email":39},{"facility":90,"status":76,"city":91,"state":39,"zip":92,"country":79,"countryCode":80,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Skane University Hospital","Lund","S-22242",{"type":82,"coordinates":94},[95,96],13.19321,55.70584,{"lat":96,"lon":95},[99],{"name":100,"role":66,"phone":39,"phoneExt":39,"email":39},"Johan Linderoth, MD, Phd",{"facility":102,"status":76,"city":103,"state":39,"zip":104,"country":79,"countryCode":80,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Orebro University Hospital","Örebro","S-70185",{"type":82,"coordinates":106},[107,108],15.2066,59.27412,{"lat":108,"lon":107},[111],{"name":112,"role":66,"phone":39,"phoneExt":39,"email":39},"Jenny Kahlmeter Brandell",{"facility":114,"status":76,"city":115,"state":39,"zip":116,"country":79,"countryCode":80,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Karolinska University Hospital","Solna","S-17176",{"type":82,"coordinates":118},[119,120],18.00086,59.36004,{"lat":120,"lon":119},[123,125],{"name":124,"role":66,"phone":39,"phoneExt":39,"email":39},"Marzia Palma, MD, PhD",{"name":126,"role":127,"phone":39,"phoneExt":39,"email":39},"Lotta Hansson","SUB_INVESTIGATOR",{"facility":129,"status":76,"city":130,"state":39,"zip":131,"country":79,"countryCode":80,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Umea University Hospital","Umeå","S-90737",{"type":82,"coordinates":133},[134,135],20.25972,63.82842,{"lat":135,"lon":134},[138],{"name":139,"role":66,"phone":39,"phoneExt":39,"email":39},"Ann-Sofie Johansson, MD, PhD",{"facility":5,"status":76,"city":141,"state":39,"zip":142,"country":79,"countryCode":80,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Uppsala","S-75185",{"type":82,"coordinates":144},[145,146],17.63889,59.85882,{"lat":146,"lon":145},[149],{"name":62,"role":66,"phone":39,"phoneExt":39,"email":39},{"type":63,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Daniel Molin","MD, PhD, associate professor",[154,155,157,159,160,161,163,166],{"name":75,"class":6},{"name":156,"class":6},"University Hospital, Umeå",{"name":158,"class":6},"Region Örebro County",{"name":114,"class":6},{"name":90,"class":6},{"name":162,"class":6},"University Hospital, Linkoeping",{"name":164,"class":165},"Skandion Clinic","UNKNOWN",{"name":167,"class":6},"Swedish Cancer Society","100583997",false,"NCT06883604","Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin","Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin","PRO-Hodgkin","Inclusion Criteria:\n\n* Histological diagnosis of classic Hodgkin Lymphoma.\n* Ann Arbour stage 1A, 1B or 2A.\n* Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)\\>50, more than two involved sites.\n* Supra diaphragmal disease.\n* Age 18-60 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n* Initial staging positron emission tomography\u002Fcomputed tomography (PET\u002FCT).\n* Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors.\n* For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy.\n* Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy.\n* Written informed consent obtained prior to any study specific procedures.\n* Women of reproductive age must agree to use contraceptives during the study treatment period.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Serious concomitant systemic disorder endangering treatment delivery.\n* More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.\n* Clinical or radiographic stable disease (SD)\u002F progressive disease (PD) during induction chemotherapy.\n* Not able to comply with treatment and study procedures.\n* No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.","ALL","18 Years","60 Years",{"count":179,"type":180},75,"ESTIMATED","INTERVENTIONAL",[41],"Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delivered in a safe way to Hodgkin Lymphoma patients with less late side effects than conventional radiotherapy, while retaining the high cure rate.\n\nThis is a multicentre phase II study of PBS proton beam therapy in patients ≤60 years, with early stage Hodgkin Lymphoma treated with induction chemotherapy. The study is performed in a non-inferiority setting comparing with a historical population-based consecutive Swedish material. The control group was treated according to the same principles, except that the radiotherapy was delivered with photons.",[185],"Hodgkin Lymphoma",[49],"2025-03-15",{"date":189,"type":190},"2025-03-19","ACTUAL",{"date":192,"type":190},"2019-09-01",{"date":194,"type":180},"2041-06",{"name":5,"class":6},6]