Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT06977594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, placebo-controlled, parallel-group, open-label, clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypersensitivity reaction incidence', 'timeFrame': '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).', 'description': "Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / 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."}], 'secondaryOutcomes': [{'measure': 'Chemotherapy completion rate', 'timeFrame': 'From chemotherapy initiation to the last cycle in each patient, an average of 6 months', 'description': 'Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.'}, {'measure': 'Severity of hypersensitivity reaction', 'timeFrame': '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).', 'description': 'Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': "Patients' quality of life", 'timeFrame': 'From chemotherapy initiation to the last cycle, an average of 6 months', 'description': "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."}, {'measure': 'Tumor Response Rate', 'timeFrame': 'At every third chemotherapy cycle in each patient', 'description': '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.'}, {'measure': 'Survival rate', 'timeFrame': 'At study completion in each patient, an average of 1 year', 'description': 'Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy.'}, {'measure': 'Recurrence Rate', 'timeFrame': 'At study completion in each patient, an average of 1 year', 'description': 'Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune tolerance induction', 'Desensitization', 'Drug hypersensitivity', 'Chemotherapy'], 'conditions': ['Ovarian Cancer', 'Endometrial Cancer', 'Cervical Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT06977594', 'briefTitle': 'Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PINTO_C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication', 'description': '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.', 'interventionNames': ['Other: Proactive immune tolerance induction', 'Drug: Paclitaxel and carboplatin', 'Drug: Standard premedication (20 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication', 'description': 'Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.', 'interventionNames': ['Other: Standard Treatment', 'Drug: Paclitaxel and carboplatin', 'Drug: Standard premedication (20 mg)']}, {'type': 'EXPERIMENTAL', 'label': '(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication', 'description': '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.', 'interventionNames': ['Other: Proactive immune tolerance induction', 'Drug: Paclitaxel and carboplatin', 'Drug: Reduced premedication (10 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication', 'description': 'Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.', 'interventionNames': ['Other: Standard Treatment', 'Drug: Paclitaxel and carboplatin', 'Drug: Standard premedication (20 mg)']}, {'type': 'EXPERIMENTAL', 'label': '(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication', 'description': '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.', 'interventionNames': ['Other: Proactive immune tolerance induction', 'Drug: Paclitaxel and carboplatin', 'Drug: Reduced premedication (5 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication', 'description': 'Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.', 'interventionNames': ['Other: Standard Treatment', 'Drug: Paclitaxel and carboplatin', 'Drug: Standard premedication (20 mg)']}], 'interventions': [{'name': 'Proactive immune tolerance induction', 'type': 'OTHER', 'description': 'Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles', 'armGroupLabels': ['(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication', '(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication', '(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication']}, {'name': 'Standard Treatment', 'type': 'OTHER', 'description': 'Standard treatment throughout all chemotherapy cycles', 'armGroupLabels': ['(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication']}, {'name': 'Paclitaxel and carboplatin', 'type': 'DRUG', 'description': 'A chemotherapy regimen for gynecologic cancers.', 'armGroupLabels': ['(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication', '(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication', '(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication', '(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication']}, {'name': 'Standard premedication (20 mg)', 'type': 'DRUG', 'description': 'Premedication includes 20 mg of dexamethasone.', 'armGroupLabels': ['(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication', '(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication', '(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication']}, {'name': 'Reduced premedication (10 mg)', 'type': 'DRUG', 'description': 'Premedication includes 20 mg of dexamethasone.', 'armGroupLabels': ['(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication']}, {'name': 'Reduced premedication (5 mg)', 'type': 'DRUG', 'description': 'Premedication includes 5 mg of dexamethasone.', 'armGroupLabels': ['(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hye-Ryun Kang, MD, PhD', 'role': 'CONTACT', 'email': 'helenmed@snu.ac.kr', 'phone': '+82-2-2072-0820'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hye-Ryun Kang, MD, PhD', 'role': 'CONTACT', 'email': 'helenmed@snu.ac.kr', 'phone': '+82-2-2072-0820'}, {'name': 'Jiyeon Park, MD', 'role': 'CONTACT', 'email': 'creativepennant@snu.ac.kr', 'phone': '+82-2-2072-3291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to institutional policies regarding data confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, {'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hye-Ryun Kang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}