[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522185":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"neo-adjuvant and adjuvant braf\u002Fmek-inhibition","EXPERIMENTAL","Participants will undergo neo-adjuvant treatment with dabrafenib\u002Ftrametinib. After 6 weeks of BRAF\u002FMEK inhibitors, participants will undergo an evaluation of resectability. If the tumor is resectable, patients undergo tumor resection. If not resectable, neo-adjuvant treatment continues for another 6 weeks followed by a new evaluation. All resected patients receive adjuvant dabrafenib\u002Ftrametinib up to a total treatment duration of 52 weeks. If resection is not possible, patients will continue on dabrafenib\u002Ftrametinib.",[13],"Drug: dabrafenib\u002Ftrametinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","dabrafenib\u002Ftrametinib","braf\u002Fmek-inhibition",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ellen Kapiteijn, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0031-71-5263486","h.w.kapiteijn@lumc.nl",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Saskia Luelmo, MD","0031-71-5263464","S.A.C.Luelmo@lumc.nl",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ellen Kapiteijn","RECRUITING","Leiden","South Holland","2300RC","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.49306,52.15833,{"lat":47,"lon":46},[50],{"name":23,"role":27,"phone":51,"phoneExt":20,"email":29},"+31715263486",{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"HW Kapiteijn","MD, PhD",[56],{"name":57,"class":58},"Novartis","INDUSTRY","100522185","phase-2-neo--and-adjuvant-targeted-therapy-in-braf-mutated-anaplastic-cancer-of-the-thyroid-neo-atact-study-100522185",false,"NCT06079333","NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)","NEO-ATACT","Inclusion Criteria:\n\n1. Informed consent.\n2. Age over 18 years old.\n3. World Health Organization (WHO) Performance Status 0 or I.\n4. Histologically confirmed ATC (centrally reviewed).\n5. Confirmed presence of BRAFV600E\u002FK mutation in primary tumor tissue.\n6. No distant metastases (M0).\n7. Free or secured airway.\n8. Able to swallow pills.\n9. Patients must have undergone complete disease staging including: PET-CT scan and CT-neck\u002Fthorax\u002Fabdomen.\n10. No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies).\n11. No prior radiotherapy to site of interest.\n12. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Neutrophils ≥ 1.0x109\u002FL, Platelets ≥ 100 x109\u002FL, Hemoglobin ≥ 6.5 mmol\u002FL, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH \\\u003C 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula; or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73m2.\n13. Absence of additional severe and\u002For uncontrolled concurrent disease.\n\nExclusion Criteria:\n\n1. No informed consent.\n2. History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).\n3. Poorly differentiated transformation of previous differentiated thyroid cancer.\n4. Presence of distant metastases.\n5. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events\n6. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.\n7. Pregnancy or nursing.","ALL","18 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans.\n\nMost patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and\u002For chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF\u002FMEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF\u002FMEK inhibitor treatment.",[76],"Anaplastic Thyroid Cancer","2023-10-05",{"date":79,"type":80},"2023-10-12","ACTUAL",{"date":82,"type":80},"2023-01-01",{"date":84,"type":70},"2028-01-01",{"name":5,"class":6},1]