[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-adenoid-cystic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-adenoid-cystic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100495646","simultaneous-integrated-boost-in-carbon-ion-radiotherapy-for-head-and-neck-adenoid-cystic-carcinoma-100495646",false,"NCT05733910","Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma","Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma","SIBACIRT","Inclusion Criteria:\n\n* Histologically-proven primary head and neck ACC;\n* Unresectable stage or residual macroscopic disease after surgery or multiple microscopic margins after surgery;\n* Patient with resectable tumor but refusing surgery\n* cN0\u002FpN0 - cN1\u002FpN1 patients (only ipsilateral neck levels I and II)\n* Absence of distant metastases or oligometastatic status (patients with ≤ 3 metastatic lung or bone lesions, excluding other sites;\n* No previous radiotherapy in head and neck region;\n* Karnofsky Performance Status ≥ 70;\n* Age ≥ 18 years;\n* Written informed consent\n* Patients' ability to understand the characteristics and consequences of the clinical trial.\n\nExclusion Criteria:\n\n* Local conditions contraindicating CIRT (e.g., active infection or previous history of recurrent infections in or close to the tumor site; intratumoral necrosis in strict proximity of vessels; pre-existing skin, bone or soft tissue fistula; extended mucosal involvement by the tumor; previous surgery with flap reconstruction);\n* Tumour site in nasopharynx, pharynx and tongue base (where an exclusive CIRT treatment could be at high risk of toxicity);\n* Tumor disease involving ≥ 50% of the palate with consequent high risks of serious anatomical damage in case of significant and rapid disease response to CIRT\n* Nodal involvement \\> cN1\u002FpN1 or cN1\u002FpN1 outside ipsilateral levels I and II\n* Tumor surrounding carotid artery \\> 180° or infiltrating the vessels\n* itanium surgical implants or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and may determine uncertainties in CIRT dose distribution during treatment planning\n* Presence of any comorbidity deemed to impact on treatment toxicity;\n* Psychic or other disorders that may prevent informed consent\n* Active autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)\n* Contraindication to MRI\n* Pregnancy or breastfeeding in progress","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"NA","The investigators aim at investigating in a prospective clinical trial whether using a Simoultaneous Integrated Boost of carbon ions treatment planning approach, improving the tumor dose conformation while lowering the unintended dose to the low-risk volume, can significantly reduce the probability of toxicity without affecting Local Control.",[27,28],"Carcinoma, Adenoid Cystic","Head and Neck Cancer",[30,31,32,33,34],"adenoid cystic carcinoma","hadrontherapy","carbon ion radiation therapy CIRT","head and neck cancer","SIB","RECRUITING","2025-02-11",{"date":38,"type":39},"2025-02-13","ACTUAL",{"date":41,"type":39},"2023-11-28",{"date":43,"type":21},"2026-11-28",{"name":45,"class":46},"CNAO National Center of Oncological Hadrontherapy","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100437330","phase-2-tyrosine-kinase-inhibitors-in-metastastic-adenoid-cystic-carcinoma-100437330","NCT04974866","Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma","Tyrosine Kinase Inhibitors in the Management of Local Advanced or Metastastic Adenoid Cystic Carcinoma","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenoid cystic carcinoma\n2. Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.\n3. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and who is previously treated with chemotherapy or local treatment (e,g transarterial chemoembolization)\n4. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria\n5. 18 years or older\n6. ECOG performance status 0, 1, 2, 3\n7. Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization) are permitted providing that toxicity has resolved to ≤grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.\n8. Adequate organ function\n9. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it\n10. A patient who signed the informed consent prior to the participation of the study and who understands that he\u002Fshe has a right to withdrawal from participation in the study at any time without any disadvantages.\n\nExclusion Criteria:\n\n* 1\\. A patient with no measurable disease, or allergy to the EGFR TKIs 2. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) 4. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding 5. A pregnant or lactating patient 6. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential) 7. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study 9. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.\n\n  10\\. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.\n\n  11\\. Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc interval\\>450msec for males or \\>470msec for female.\n\n  12\\. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs",true,"90 Years",{"count":58,"type":21},20,[60],"PHASE2","There is no clinical study on epidermal growth factor receptor tyrosine kinase inhibitors has been systematically conducted in adenoid cystic carcinoma.\n\nThis is a phase II study EGFR TKIs in adenoid cystic carcinoma to evaluate its efficacy in this disease.",[27],[64,65],"Neoplasms, Glandular and Epithelial","Adenocarcinoma","2023-03-27",{"date":68,"type":39},"2023-03-29",{"date":70,"type":39},"2021-07-01",{"date":72,"type":21},"2026-07-31",{"name":74,"class":46},"Qingdao Central Hospital"]