[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591220":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":44,"studyPopulation":36,"armGroups":45,"interventions":76,"overallOfficials":36,"centralContacts":101,"locations":111,"responsibleParty":125,"collaborators":129,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":36,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":36,"enrollmentInfo":146,"targetDuration":36,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":113,"whyStopped":36,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Hypersensitivity reaction incidence","Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases \u002F total chemotherapy administrations) × 100.\n\nHypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria.","From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).",[14,18,21,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Chemotherapy completion rate","Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.","From chemotherapy initiation to the last cycle in each patient, an average of 6 months",{"measure":19,"description":20,"timeFrame":12},"Severity of hypersensitivity reaction","Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).",{"measure":22,"description":23,"timeFrame":24},"Patients' quality of life","Patients' quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better outcomes for the Global Health Status and Functional Scales, whereas higher scores on the Symptom Scales indicate worse symptoms.","From chemotherapy initiation to the last cycle, an average of 6 months",{"measure":26,"description":27,"timeFrame":28},"Tumor Response Rate","Tumor response rate is defined as the proportion of patients who experience tumor size reduction or disappearance in response to chemotherapy. It is calculated as the proportion of patients who achieve a complete response (disappearance of all tumors with no evidence of new lesions) or a partial response (at least a 30% reduction in the size of tumors, with no appearance of new lesion) after planned chemotherapy.","At every third chemotherapy cycle in each patient",{"measure":30,"description":31,"timeFrame":32},"Survival rate","Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy.","At study completion in each patient, an average of 1 year",{"measure":34,"description":35,"timeFrame":32},"Recurrence Rate","Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","A randomized, placebo-controlled, parallel-group, open-label, clinical trial","PREVENTION",{"masking":43,"maskingDescription":36,"whoMasked":36},"NONE","Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.",[46,54,60,65,68,73],{"label":47,"type":48,"description":49,"interventionNames":50},"(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication","EXPERIMENTAL","Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone.",[51,52,53],"Other: Proactive immune tolerance induction","Drug: Paclitaxel and carboplatin","Drug: Standard premedication (20 mg)",{"label":55,"type":56,"description":57,"interventionNames":58},"(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication","ACTIVE_COMPARATOR","Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.",[59,52,53],"Other: Standard Treatment",{"label":61,"type":48,"description":62,"interventionNames":63},"(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication","Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone.",[51,52,64],"Drug: Reduced premedication (10 mg)",{"label":66,"type":56,"description":57,"interventionNames":67},"(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication",[59,52,53],{"label":69,"type":48,"description":70,"interventionNames":71},"(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication","Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone.",[51,52,72],"Drug: Reduced premedication (5 mg)",{"label":74,"type":56,"description":57,"interventionNames":75},"(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication",[59,52,53],[77,81,85,90,94,97],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":36},"Proactive immune tolerance induction","Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles",[47,61,69],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":36},"Standard Treatment","Standard treatment throughout all chemotherapy cycles",[55,66,74],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":36},"DRUG","Paclitaxel and carboplatin","A chemotherapy regimen for gynecologic cancers.",[47,55,61,66,69,74],{"type":86,"name":91,"description":92,"armGroupLabels":93,"otherNames":36},"Standard premedication (20 mg)","Premedication includes 20 mg of dexamethasone.",[47,55,66,74],{"type":86,"name":95,"description":92,"armGroupLabels":96,"otherNames":36},"Reduced premedication (10 mg)",[61],{"type":86,"name":98,"description":99,"armGroupLabels":100,"otherNames":36},"Reduced premedication (5 mg)","Premedication includes 5 mg of dexamethasone.",[69],[102,107],{"name":103,"role":104,"phone":105,"phoneExt":36,"email":106},"Hye-Ryun Kang, MD, PhD","CONTACT","+82-2-2072-0820","helenmed@snu.ac.kr",{"name":108,"role":104,"phone":109,"phoneExt":36,"email":110},"Jiyeon Park, MD","+82-2-2072-3291","creativepennant@snu.ac.kr",[112],{"facility":5,"status":113,"city":114,"state":36,"zip":115,"country":116,"countryCode":36,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"RECRUITING","Seoul","03080","South Korea",{"type":118,"coordinates":119},"Point",[120,121],126.9784,37.566,{"lat":121,"lon":120},[124],{"name":103,"role":104,"phone":105,"phoneExt":36,"email":106},{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Hye-Ryun Kang","Professor",[130,132,134],{"name":131,"class":6},"Seoul National University Bundang Hospital",{"name":133,"class":6},"Seoul National University Boramae Hospital",{"name":135,"class":136},"Korea Health Industry Development Institute","OTHER_GOV","100591220","proactive-immune-tolerance-induction-in-chemotherapy-for-gynecologic-cancer-100591220",false,"NCT06977594","Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer","A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer","Inclusion Criteria:\n\n* Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies.\n* Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin.\n* Patients who are able to read and voluntarily provide written informed consent.\n* Aged 19 years or older.\n\nExclusion Criteria:\n\n* Patients who do not wish to participate in this study voluntarily.\n* Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.","FEMALE","19 Years",{"count":147,"type":148},1000,"ESTIMATED","INTERVENTIONAL",[151],"NA","The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer.\n\nThe main questions it aims to answer are:\n\n\\- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles?\n\nParticipants will:\n\n* Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment.\n* Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.",[154,155,156],"Ovarian Cancer","Endometrial Cancer","Cervical Cancer",[158,159,160,161],"Immune tolerance induction","Desensitization","Drug hypersensitivity","Chemotherapy","2026-10-02",{"date":164,"type":165},"2026-10-07","ACTUAL",{"date":167,"type":165},"2025-05-21",{"date":169,"type":148},"2028-05-31",{"name":5,"class":6},1]