[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552398":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic radiotherapy","EXPERIMENTAL","Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin",[13],"Radiation: Stereotactic radiotherapy boost",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Stereotactic radiotherapy boost","A stereotactic radiosurgery boost is given in two cases:\n\n* Upfront boost-on the first day of overall treatment time (OTT) (to 6 days before beginning conventional radiotherapy).\n* Direct boost-on Days 43-49 of OTT in relation to conventional radiotherapy to total dose (TD) 70 Gy, i.e., up to 6 days after a dose of 60 Gy.\n\nTreatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin 100 mg\u002Fm2 or 40 mg\u002Fm2 in a 21-day or 7-day cycle, respectively\n\nPatients who start the treatment from induction chemotherapy may have a chance to qualify for an upfront or direct boost, depending the evaluation of the response to systemic treatment\n\nPrescribed doses of stereotactic boost are in the range of 10-18 Gy",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Paweł Polanowski","Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Paweł Polanowski, PhD","CONTACT","48322788313","pawel.polanowski@gliwice.nio.gov.pl",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Krzysztof Skladowski","48322788329","krzysztof.skladowski@gliwice.nio.gov.pl",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,","RECRUITING","Gliwice","Gliwicw","44-102","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],18.67658,50.29761,{"lat":49,"lon":48},[52,54],{"name":53,"role":29,"phone":30,"phoneExt":20,"email":31},"Pawel Polanowski",{"name":55,"role":25,"phone":20,"phoneExt":20,"email":20},"Pawel Polanowski, PhD",{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100552398","stereotactic-radiosurgery-in-patients-with-head-and-neck-region-tumours-100552398",false,"NCT06472570","Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours","Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours","Inclusion Criteria:\n\n1. Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H\\&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.\n2. Patients with other malignant tumours of the H\\&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.\n3. Patients with nonmalignant tumours of the H\\&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.\n4. Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12\n5. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n6. Conscious agreement to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Do not meet the inclusion criteria.\n2. Decompensated diabetes mellitus.\n3. Myocardial infarction occurred up to 6 months before.\n4. Pregnancy.\n5. Mental disorder preclusive of making a conscious agreement","ALL","18 Years","80 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\\&N tumours.",[76],"Head and Neck Cancer",[78,79,80],"stereotactic radiotherapy","radiosurgery boost","head and neck cancer","2024-06-24",{"date":83,"type":84},"2024-06-25","ACTUAL",{"date":86,"type":84},"2019-10-26",{"date":88,"type":70},"2030-12-31",{"name":5,"class":6},1]