[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Man Hu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100619122","phase-3-proton-vs-photon-imrt-in-locally-advanced-nasopharyngeal-carcinoma-a-phase-iii-trial-100619122",false,"NCT07340515","Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial","A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age 18 to 70 years\n* Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)\n* High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system\n* No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Adequate organ function as defined in the study protocol\n* Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol\n* Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis (M1 disease)\n* Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma\n* Active autoimmune disease requiring systemic therapy\n* Uncontrolled infection or severe comorbidities that may affect treatment tolerance\n* Pregnancy or breastfeeding\n* Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation","ALL","18 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.\n\nAll patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase.\n\nThe primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.",[27],"Nasopharyngeal Carcinoma (NPC)",[29,30,31,32,33],"Proton Therapy","IMPT","Intensity-Modulated Proton Therapy","Nasopharyngeal Carcinoma","Chemoradiotherapy","RECRUITING","2026-01-13",{"date":37,"type":38},"2026-01-14","ACTUAL",{"date":40,"type":21},"2025-12-15",{"date":42,"type":21},"2031-12-31",{"name":44,"class":45},"Man Hu","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100592992","phase-3-phase-iii-non-inferiority-trial-of-proton-versus-photon-therapy-for-nasopharyngeal-carcinoma-100592992","NCT07000643","Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma","Proton Therapy Versus Photon Therapy for the Treatment of Nasopharyngeal Carcinoma: A Prospective, Open-Label, Multicenter, Phase III Non-Inferiority Clinical Trial","Inclusion Criteria:\n\nSigned written informed consent prior to the implementation of any trial-related procedures; No gender restriction, age ≥18 years and ≤75 years; Histologically confirmed, according to the latest WHO classification, including keratinizing carcinoma, non-keratinizing differentiated carcinoma, and undifferentiated carcinoma; Investigator-assessed nasopharyngeal carcinoma (cT1-4N0-3M0, AJCC 9th Edition); No prior systemic anti-tumor therapy for locally advanced disease; ECOG performance status 0-1;\n\nAdequate organ function, subjects must meet the following laboratory parameters:\n\nAbsolute neutrophil count (ANC) ≥1.5x10⁹\u002FL. Platelets ≥75×10⁹\u002FL. Hemoglobin ≥9 g\u002FdL (90 g\u002FL) or ≥5.6 mmol\u002FL; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN (Upper Limit of Normal) Serum creatinine ≤1.5×ULN AND creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml\u002Fmin; Good coagulation function: simple laboratory abnormalities judged by the investigator to be without clinical significance; Myocardial enzyme spectrum: simple laboratory abnormalities judged by the investigator to be without clinical significance; (Note: The document lists this as criteria 8 under 3.2.1 in the main text, but the synopsis table formatting places it slightly differently though it appears to be the last point of item 7 in structure. For clarity, listing as a separate main point as per the detailed protocol structure.)\n\nExclusion Criteria:\n\nPresence of distant metastatic lesions (M1). Primary squamous cell carcinoma of the head and neck not originating in the nasopharynx.\n\nDiagnosis of types other than nasopharyngeal keratinizing carcinoma and non-keratinizing carcinoma; (Note: The inclusion criteria state WHO types: keratinizing, non-keratinizing differentiated, and undifferentiated. This exclusion seems to narrow it further or implies a nuance. This is a direct translation of the source.) Currently participating in an interventional clinical research treatment; Contraindications to radiotherapy;\n\nUntreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal at the respective study center's laboratory); Note: Hepatitis B subjects meeting the following criteria may also be enrolled:\n\nHBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose; subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation.\n\nFor subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\n\nActive HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Pregnant women;\n\nPresence of any severe or uncontrolled systemic diseases, for example:\n\nSignificant and symptomatically severe, difficult-to-control abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation\\[cite: 2\\]; Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥ 2; Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack\\[cite: 2\\]; History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or currently active interstitial lung disease; Active pulmonary tuberculosis; Active or uncontrolled infection requiring systemic therapy; Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; Liver diseases such as severe cirrhosis, decompensated liver disease, acute or chronic active hepatitis; Patients with mental disorders who cannot cooperate with treatment; History of illness or disease, treatment, or abnormal laboratory values that could interfere with study results, hinder the subject's full participation in the study, or other situations deemed unsuitable for enrollment by the investigator; or if the investigator believes there are other potential risks making the subject unsuitable for this study","75 Years",{"count":56,"type":21},386,[24],"This study is a prospective, open-label, multicenter, cohort, phase III non-inferiority clinical trial comparing proton therapy with photon radiotherapy for nasopharyngeal carcinoma. It intends to enroll histologically confirmed newly diagnosed nasopharyngeal carcinoma patients without distant metastasis (M0). Through a prospective 1:1 matched cohort study design, patients will be divided into the intensity-modulated proton therapy (IMPT) group and the intensity-modulated radiation therapy (IMRT) group. Systemic treatment regimens are formulated according to clinical guidelines.",[32],[61,62,63],"Nasopharyngeal carcinoma","proton radiotherapy","target area delineation","2025-05-24",{"date":66,"type":38},"2025-06-03",{"date":68,"type":38},"2025-05-07",{"date":70,"type":21},"2029-02-28",{"name":44,"class":45},""]