[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636238":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery plus Postoperative Radiotherapy Group",null,"Surgery plus Postoperative Radiotherapy:Participants in this group undergo radical surgical resection of the tumor (R0 resection) followed by postoperative intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) at a dose of 60-66 Gy to the high-risk clinical target volume (CTV1) and 54-60 Gy to the low-risk CTV2. Radiotherapy is initiated within 4-6 weeks after surgery.",[13],"Radiation: Postoperative Radiotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgery Alone (Observation) Group","No postoperative radiotherapy or any other form of adjuvant radiation. Patients undergo regular follow-up according to the study protocol, including physical examination, laboratory tests, and imaging (contrast-enhanced MRI of the head and neck every 6 months for the first 3 years and annually thereafter; chest CT annually). Active surveillance is performed to detect any recurrence or metastasis.",[18],"Other: Observation",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"RADIATION","Postoperative Radiotherapy","Intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) delivered to the postoperative tumor bed. High-risk clinical target volume (CTV1) receives 60-66 Gy in 30-33 fractions (1.8-2.0 Gy per fraction). Low-risk clinical target volume (CTV2) receives 54-60 Gy in 30-33 fractions. Treatment starts within 4-6 weeks after surgery. Daily image guidance is used. Organs at risk are constrained according to QUANTEC\u002FRTOG guidelines",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Observation","No postoperative radiotherapy or any other form of adjuvant radiation. Patients undergo regular follow-up according to the study protocol, including physical examination, laboratory tests, and imaging (contrast-enhanced MRI of the head and neck every 6 months for the first 3 years and annually thereafter; chest CT annually). Active surveillance is performed to detect any recurrence or metastasis",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Quan Liu, MD","CONTACT","+86 15001959681","liuqent@163.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Wanpeng Li, MD","+86 13262856870","18879117831@163.com",[40],{"facility":5,"status":10,"city":41,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Shanghai","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,53],{"name":52,"role":32,"phone":37,"phoneExt":10,"email":38},"Wanpeng Li",{"name":54,"role":32,"phone":33,"phoneExt":10,"email":34},"Quan Liu, MD, PhD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Quan Liu","Director of Skull Base Adenoid Cystic Carcinoma Center; Chief Physician of Otolaryngology Department","100636238","spare-1st-surgery-alone-vs-surgery-plus-postoperative-radiotherapy-for-sinonasal-adenoid-cystic-carcinoma-100636238",false,"NCT07563088","SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma","Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study","SPARE-1st","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Histologically confirmed adenoid cystic carcinoma of cribriform or tubular type (solid type excluded) by central pathology review.\n* Completed radical surgical resection with postoperative pathology confirming R0 resection (negative microscopic margins).\n* Tumor stage T1, T2, or T3 according to AJCC 8th edition, with N0 and M0 status.\n* Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region).\n* ECOG performance status 0 or 1.\n* Adequate bone marrow, liver, and kidney function within 14 days before enrollment:\n\n  * Absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN.\n  * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Tumor stage T4, or presence of regional lymph node metastasis (N+), or distant metastasis (M1).\n* Postoperative pathology showing positive margins (R1 or R2).\n* Prior head and neck radiotherapy.\n* Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Uncontrolled serious concomitant disease (e.g., unstable angina, recent myocardial infarction, uncontrolled hypertension).\n* Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.\n* Psychological, social, or geographic factors that may interfere with study compliance.","ALL","18 Years","75 Years",{"count":71,"type":72},200,"ESTIMATED","OBSERVATIONAL","Background:\n\nSinonasal adenoid cystic carcinoma (ACC) is a rare type of cancer that starts in the nasal cavity or sinuses. Although surgery can remove the tumor, doctors often recommend radiation therapy after surgery to reduce the chance of the cancer coming back. However, radiation can cause long-term side effects such as bone damage, dry mouth, or difficulty opening the mouth. For patients whose tumor has been completely removed (called R0 resection) and who have early-stage disease (T1-T3) without spread to lymph nodes or other organs, it is not clear whether routine radiation therapy is always needed.\n\nStudy Objective:\n\nThis study aims to find out whether simply watching and waiting (surgery alone) is not worse than adding radiation therapy (surgery plus radiation) in terms of keeping patients free from cancer for at least 3 years. If surgery alone is shown to be as good as surgery plus radiation, some patients may be able to avoid the side effects of radiation.\n\nStudy Design:\n\nThis is a prospective, multicenter, real-world study. It is not a randomized trial - patients and their doctors will decide together whether to have radiation after surgery. We will follow about 200 patients from many hospitals across China. About half will receive surgery alone, and the other half will receive surgery followed by radiation therapy. All patients will be followed for at least 3 years.\n\nHypothesis:\n\nWe hypothesize that surgery alone is not inferior to surgery plus radiation therapy for 3-year disease-free survival, with a non-inferiority margin of a hazard ratio of 1.35. In other words, even if surgery alone has a slightly higher risk of cancer returning, the difference is small enough that avoiding radiation side effects may still be worthwhile.\n\nMain Outcome:\n\nThe main outcome is the percentage of patients who are alive and free from cancer recurrence (local, regional, or distant) or death from any cause at 3 years after treatment.\n\nPotential Impact:\n\nIf our hypothesis is confirmed, this study could change current practice. Many patients with completely resected, early-stage sinonasal ACC might safely avoid postoperative radiation and its long-term side effects, improving their quality of life without compromising cancer control.",[76,77],"Adenoid Cystic Carcinoma","Sinonasal Carcinoma",[79,80,81,82,83,84,85,86],"Sinonasal Adenoid Cystic Carcinoma","Radiotherapy","Adjuvant","Watchful Waiting","Observational Study","Prospective Studies","Non-Inferiority Trials","Disease-Free Survival","NOT_YET_RECRUITING","2026-05-08",{"date":90,"type":91},"2026-05-12","ACTUAL",{"date":93,"type":72},"2026-05-01",{"date":95,"type":72},"2032-05-01",{"name":5,"class":6},1]