[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638676":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Guangzhou Concord Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton therapy group","EXPERIMENTAL","All patients received proton therapy, with a prescribed dose of 70Gy in 33 fractions, 5 days per week, for a total of 6.5 weeks.",[13],"Radiation: Proton Therapy System (ProBeam)",{"label":15,"type":16,"description":17,"interventionNames":18},"Photon therapy group","PLACEBO_COMPARATOR","All patients received photon therapy, with a prescribed dose of 70Gy in 33 fractions, 5 days per week, for a total of 6.5 weeks.",[19],"Radiation: Photon Therapy System (TrueBeam)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Proton Therapy System (ProBeam)","Treatment planning and target delineation: All patients were in the supine position with the head extended backward, with the mask fixed, and enhanced computed tomography (CT) scans were performed for positioning. The slice thickness was 1.25mm. The gross tumor volume (GTV) included the recurrent primary lesion. The clinical target volume (CTV) included the anatomical expansion of the tumor and the suspicious lesions visible under the microscope. CTV specific delineation refers to the Chinese Nasopharyngeal Carcinoma Radiotherapy Guidelines (2022 edition).Radiation dose and treatment plan: The prescribed dose was 70 Gray (Gy) delivered in 33 fractions. Physicists design intensity-modulated proton therapy plans according to the physician's requirements. After the radiotherapy plan was designed, it was evaluated and repeatedly optimized by the physician and the physicist until satisfactory results were achieved. Treatment: was required for each treatment session.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Photon Therapy System (TrueBeam)","Treatment planning and target delineation: All patients were in the supine position with the head extended backward, with the mask fixed, and enhanced computed tomography (CT) scans were performed for positioning. The slice thickness was 1.25mm. The gross tumor volume (GTV) included the recurrent primary lesion. The clinical target volume (CTV) included the anatomical expansion of the tumor and the suspicious lesions visible under the microscope. CTV specific delineation refers to the Chinese Nasopharyngeal Carcinoma Radiotherapy Guidelines (2022 edition).Radiation dose and treatment plan: The prescribed dose was 70 Gray (Gy) delivered in 33 fractions. Physicists design intensity-modulated photon therapy plans according to the physician's requirements. After the radiotherapy plan was designed, it was evaluated and repeatedly optimized by the physician and the physicist until satisfactory results were achieved. Treatment: was required for each treatment session.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Taize Yuan","CONTACT","8620-32506195","taize.yuan@ccm.cn",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100638676","a-multicenter-prospective-phase-iii-clinical-study-of-proton-intensity-modulated-radiotherapy-versus-photon-intensity-modulated-radiotherapy-for-untreated-non-metastatic-nasopharyngeal-carcinoma-100638676",false,"NCT07578727","A Multicenter, Prospective, Phase III Clinical Study of Proton Intensity-modulated Radiotherapy Versus Photon Intensity-modulated Radiotherapy for Untreated Non-metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Diagnosed by histology and\u002For cytology as non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, i.e., WHO type II or III).\n2. Clinical stage: T1-4N0-3M0, I-III stage (AJCC 9th edition).\n3. Age: ≥ 18 years old, ≤ 70 years old.\n4. Gender: No restrictions.\n5. ECOG ≤ 1.\n6. Good organ function:\n\n   Normal bone marrow function: WBC ≥ 4×109\u002FL, Platelet ≥ 100×109\u002FL, HGB ≥ 90g\u002FL Total bilirubin, AST, ALT ≤ 2.0× upper limit of normal value; Creatinine clearance rate ≥ 60ml\u002Fmin or Creatinine ≤ 1.5× upper limit of normal value.\n7. The patient has signed the informed consent form and is willing and able to comply with the study visit schedule, treatment plan, laboratory tests and other research procedures.\n\nExclusion Criteria:\n\n1. The patient has a poor general condition and is in a state of poor health; or the patient has already experienced metastasis.\n2. The patient has an uncontrolled severe infectious disease.\n3. The patient has severe diseases or complications in the heart, lungs, liver, kidneys or other systems, and the investigator judges that they cannot complete the clinical trial.\n4. There are implants such as artificial ears or dentures within the radiotherapy range, and the investigator judges that they are not suitable for proton therapy.\n5. The patient has a history of radiotherapy in the head and neck region.\n6. The patient has mental illness, drug abuse or alcohol dependence.","ALL","18 Years","70 Years",{"count":49,"type":50},504,"ESTIMATED","INTERVENTIONAL",[53],"NA","Proton therapy for nasopharyngeal carcinoma can reduce radiotherapy-related toxic reactions, and some retrospective studies have found that proton therapy improves the survival of patients with nasopharyngeal carcinoma. However, high-level prospective clinical evidence is still lacking. This study aims to investigate the efficacy and side effects of proton therapy compared with photon intensity-modulated radiotherapy for nasopharyngeal carcinoma through a multicenter, prospective, phase III clinical trial, providing more high-quality evidence-based medical evidence for proton therapy of nasopharyngeal carcinoma.",[56],"Nasopharyngeal Carcinoma (NPC)",[58,59],"proton therapy","nasopharyngeal carcinoma","NOT_YET_RECRUITING","2026-05-13",{"date":63,"type":64},"2026-05-15","ACTUAL",{"date":66,"type":50},"2026-05-01",{"date":68,"type":50},"2028-12-30",{"name":5,"class":6}]