[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580265":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":48,"centralContacts":57,"locations":63,"responsibleParty":188,"collaborators":25,"id":190,"slug":25,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":191,"sex":197,"minAge":198,"maxAge":25,"enrollmentInfo":199,"targetDuration":25,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Swiss Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Treatment","EXPERIMENTAL","Trial treatment consists of 3 neoadjuvant cycles of doxorubicin with either ifosfamide or dacarbazine (the latter only in case of leiomyosarcoma) combined with hyperthermia (HT), followed by radiotherapy (RT) and surgery. Each chemotherapy cycle will last 3 weeks. Trial treatment will last approximately 20 weeks. After surgery, a follow-up period of 36 months per patient is foreseen.",[13,14,15,16,17,18],"Drug: Doxorubicin","Drug: Ifosfamide","Drug: Dacarbazine","Other: Hyperthermia","Radiation: Radiotherapy","Procedure: Surgery",[20,26,30,34,38,43],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Doxorubicin","Trial treatment consists of 3 neoadjuvant cycles of doxorubicin with either ifosfamide or dacarbazine (the latter only in case of leiomyosarcoma). Doxorubicin will be given at a dose of 75 mg\u002Fm2 Body surface area (BSA) on day 1 of each cycle as a intravenous infusion over 15 minutes.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Ifosfamide","Trial treatment consists of 3 neoadjuvant cycles of doxorubicin with either ifosfamide or dacarbazine (the latter only in case of leiomyosarcoma). Ifosfamide will be given at a dose of 3 g\u002Fm2 BSA on days 1 to 3 of each cycle, for a total dose per cycle of 9 g\u002Fm2 BSA, as an intravenous infusion of 3 g\u002Fm2 daily over 4 hours.",[9],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Dacarbazine","Trial treatment consists of 3 neoadjuvant cycles of doxorubicin with either ifosfamide or dacarbazine (the latter only in case of leiomyosarcoma). Dacarbazine will be given at a daily dose of 300 mg\u002Fm2 BSA on days 1 to 3 of each cycle, for a total dose per cycle of 900 mg\u002Fm2 BSA, as an intravenous infusion over 30 minutes.",[9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":25},"Hyperthermia","Hyperthermia (HT) sessions are scheduled on days 1 and 3 of each chemotherapy cycle. The duration of the preheating phase is always 30 minutes. Together with the treatment phase of 60 minutes, the duration of a HT session is uniformly 90 minutes (Total treatment time). On days 2, chemotherapy will be applied without HT.",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":25},"RADIATION","Radiotherapy","Radiotherapy (RT) treatment should start ideally 19 days after last chemotherapy dose received (range -4 \u002F +7), preferably on a Monday to omit that the last RT fractions will be applied directly after the weekend. Start of RT can be postponed up to 14 days due to medical reasons without violating treatment protocol.\n\nPatients will preferably receive normofractionated RT to a total dose of 50 Gy in 25 fractions of 2 Gy over 5 weeks23.\n\nAlternatively, patients can receive a moderate hypofractionated RT to either a total dose of 42.75 Gy in 15 fractions of 2.85 Gy over 3 weeks or a total dose of 42 Gy in 14 fractions of 3 Gy over 2 weeks and four days41. The respective total treatment time changes respectively.\n\nThe RT treatment should be delivered once daily except on weekends.",[9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":25},"PROCEDURE","Surgery","Standard of care surgical resection must be done by an experienced sarcoma surgeon. All lesions of the trunk and extremities will be resected after total neoadjuvant treatment with chemotherapy, HT and RT.\n\nSurgery will take place preferentially 6 weeks (+\u002F- 2 weeks) after end of radiation.",[9],[49,53],{"name":50,"affiliation":51,"role":52},"Emanuel Stutz, MD","Insel Gruppe AG, University Hospital Bern","STUDY_DIRECTOR",{"name":54,"affiliation":55,"role":56},"Attila Kollàr, MD","University of Bern","STUDY_CHAIR",[58],{"name":59,"role":60,"phone":61,"phoneExt":25,"email":62},"Gwendoline Wicki","CONTACT","+41 31 389 91 91","trials@sakk.ch",[64,84,99,114,128,143,158,173],{"facility":65,"status":66,"city":67,"state":25,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Kantonsspital Aarau","RECRUITING","Aarau","5001","Switzerland","CH",{"type":72,"coordinates":73},"Point",[74,75],8.04422,47.39254,{"lat":75,"lon":74},[78,82],{"name":79,"role":60,"phone":80,"phoneExt":25,"email":81},"Oliver Riesterer, Prof.","+41 62 838 42 49","oliver.riesterer@ksa.ch",{"name":79,"role":83,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":85,"status":66,"city":86,"state":25,"zip":87,"country":69,"countryCode":70,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Universitaetsspital Basel","Basel","CH-4031",{"type":72,"coordinates":89},[90,91],7.57327,47.55839,{"lat":91,"lon":90},[94,98],{"name":95,"role":60,"phone":96,"phoneExt":25,"email":97},"Fatime Krasniqi, MD","+41 61 265 50 59","fatime.krasniqi@usb.ch",{"name":95,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":100,"status":66,"city":101,"state":25,"zip":102,"country":69,"countryCode":70,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"EOC - Istituto Oncologico della Svizzera Italiana","Bellinzona","6500",{"type":72,"coordinates":104},[105,106],9.01703,46.19278,{"lat":106,"lon":105},[109,113],{"name":110,"role":60,"phone":111,"phoneExt":25,"email":112},"Thomas Zilli, Prof","+41 91 811 86 75","segretariatoRadioterapia.IOSI@eoc.ch",{"name":110,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":115,"status":66,"city":116,"state":25,"zip":117,"country":69,"countryCode":70,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Inselspital Bern - Universitätsklinik für Radioonkologie","Bern","3010",{"type":72,"coordinates":119},[120,121],7.44744,46.94809,{"lat":121,"lon":120},[124,127],{"name":50,"role":60,"phone":125,"phoneExt":25,"email":126},"+41 31 632 26 32","emanuel.stutz@insel.ch",{"name":50,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":129,"status":66,"city":130,"state":25,"zip":131,"country":69,"countryCode":70,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"CHUV - Swiss Cancer Center Lausanne","Lausanne","1011",{"type":72,"coordinates":133},[134,135],6.63282,46.516,{"lat":135,"lon":134},[138,142],{"name":139,"role":60,"phone":140,"phoneExt":25,"email":141},"Antonia Digklia, MD","+41 21 314 79 28","Antonia.Digklia@chuv.ch",{"name":139,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":144,"status":66,"city":145,"state":25,"zip":146,"country":69,"countryCode":70,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"hoch Health Ostschweiz - Kantonsspital St. Gallen","Sankt Gallen","9007",{"type":72,"coordinates":148},[149,150],9.37477,47.42391,{"lat":150,"lon":149},[153,157],{"name":154,"role":60,"phone":155,"phoneExt":25,"email":156},"Christina Appenzeller, MD","+41 71 494 29 22","christina.appenzeller@kssg.ch",{"name":154,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":159,"status":66,"city":160,"state":25,"zip":161,"country":69,"countryCode":70,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Kantonsspital Winterthur","Winterthur","8401",{"type":72,"coordinates":163},[164,165],8.72413,47.50564,{"lat":165,"lon":164},[168,172],{"name":169,"role":60,"phone":170,"phoneExt":25,"email":171},"Ralph Zachariah, MD","+41 52 266 30 65","ralph.zachariah@ksw.ch",{"name":169,"role":83,"phone":25,"phoneExt":25,"email":25},{"facility":174,"status":66,"city":175,"state":25,"zip":176,"country":69,"countryCode":70,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Universitätsspital Zürich","Zurich","8091",{"type":72,"coordinates":178},[179,180],8.55,47.36667,{"lat":180,"lon":179},[183,187],{"name":184,"role":60,"phone":185,"phoneExt":25,"email":186},"Lorenz Bankel, MD","+41 44 255 22 14","lorenz.bankel@usz.ch",{"name":184,"role":83,"phone":25,"phoneExt":25,"email":25},{"type":189,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100580265",false,"NCT06835049","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial","TNT-HYPE","Main Inclusion Criteria:\n\n* Histologically confirmed primary high-risk Soft tissue sarcoma (STS) of extremity or trunk.\n* High-risk according to the prognostic Sarculator tool: 10-year OS probability \\\u003C 60%5.\n* Resectable tumor: resectability is based on pre-operative imaging and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only a R2 resection is feasible.\n* Measurable disease per RECIST v1.1.\n* Diagnostic biopsy is available for the central pathology review.\n* Candidate for chemotherapy regimen according to protocol.\n* Candidate for loco-regional HT.\n* Adequate bone marrow function, hepatic function, renal function, cardiac function and coagulation function.\n\nMain Exclusion Criteria:\n\n* Metastatic disease.\n* Previous Whoops resection.\n* Ex-ulcerating tumors or tumors infiltrating the skin.\n* Other invasive malignancy within 5 years, with the exception of adequately treated non melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6 prostate cancer.\n* Any previous radiotherapy (RT) or systemic therapy for the present tumor.\n* Previous treatment with maximum cumulative doses (450 mg\u002Fm² doxorubicin or equivalent 900 mg\u002Fm² epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones.\n* Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.\n* Concomitant use of other anti-cancer drugs or RT.\n* No metal implants in the region of tumor or cardiac implant electronic devices (CIEDs).\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last 12 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Active and uncontrolled infections, in particular urinary tract infections.\n* Inflammation of the urinary bladder (interstitial cystitis).\n* History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration.\n* Vaccination with live vaccines within 30 days prior to registration.\n* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).","ALL","18 Years",{"count":200,"type":201},24,"ESTIMATED","INTERVENTIONAL",[204],"PHASE2","Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.",[207],"Sarcoma,Soft Tissue",[209,195,210,9,211],"Sarcoma, soft-tissue","phase II","hyperthermia","2025-12-23",{"date":214,"type":215},"2025-12-30","ACTUAL",{"date":217,"type":215},"2025-10-27",{"date":219,"type":201},"2031-03-31",{"name":5,"class":6},8]