Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-02 @ 6:25 AM
Study NCT ID:
NCT06836492
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012509', 'term': 'Sarcoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2025-02-15', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective response rate (ORR)', 'timeFrame': 'Up to 1 year', 'description': 'The ORR was calculated based on the best overall response.'}, {'measure': 'disease control rate (DCR)', 'timeFrame': 'Up to 1 year'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'Up to 10 years', 'description': 'Furthermore, we provided Kaplan-Meier plots for PFS'}, {'measure': 'overall survival (OS)', 'timeFrame': 'Up to 10 years', 'description': 'Furthermore, we provided Kaplan-Meier plots for OS.'}], 'secondaryOutcomes': [{'measure': 'The safety of the SYSUCC-RMS regimen for pediatric RMS patients.', 'timeFrame': 'Up to 10 years', 'description': 'Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhabdomyosarcoma', 'Pediatric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose is to explore the efficacy and safety of the SYSUCC-RMS regimen for pediatric RMS patients and to explore the impact of concurrent radiotherapy and chemotherapy on the survival rate of low-risk, medium risk, high-risk, and extremely high-risk patients in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 0 years \\< age \\< 18 years old, regardless of gender;\n2. Tumor patients diagnosed by histopathology or bone marrow cytology;\n3. Patients are treated for the first time;\n4. ECoG score ≤ 2;\n5. The expected survival time is more than 8 months;\n6. Patient's parent or guardian signs informed consent.\n\nExclusion Criteria:\n\n1. Combined with immunodeficiency disease\n2. Second tumor"}, 'identificationModule': {'nctId': 'NCT06836492', 'briefTitle': 'A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.', 'orgStudyIdInfo': {'id': 'SYSUCC-RMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low risk', 'interventionNames': ['Combination Product: VAC，VAC/VII，CAV/IE']}, {'type': 'OTHER', 'label': 'Moderate risk', 'interventionNames': ['Combination Product: VAC，VAC/VII，CAV/IE']}, {'type': 'OTHER', 'label': 'High risk', 'interventionNames': ['Combination Product: VAC，VAC/VII，CAV/IE']}, {'type': 'OTHER', 'label': 'Very high risk', 'interventionNames': ['Combination Product: VAC，VAC/VII，CAV/IE']}], 'interventions': [{'name': 'VAC，VAC/VII，CAV/IE', 'type': 'COMBINATION_PRODUCT', 'description': 'Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP', 'armGroupLabels': ['High risk', 'Low risk', 'Moderate risk', 'Very high risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suying Lu', 'role': 'CONTACT', 'email': 'lusy@sysucc.org.cn', 'phone': '+020-87342460'}], 'facility': 'Suying Lu', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Suying Lu', 'role': 'CONTACT', 'email': 'lusy@sysucc.org.cn', 'phone': '+020-87342460'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yizhuo Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sun Yat-sen University Cancer Center', 'investigatorFullName': 'Yizhuo Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}