Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04799002
Status:
RECRUITING
Last Update Posted:
2021-03-16
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topotecan and Melphalan for Retinoblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eyeball-sparing rate', 'timeFrame': '5 years after chemotherapy', 'description': 'Eyeball-sparing rate during chemotherapy in retinoblastoma patients'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': '5 years after chemotherapy', 'description': 'Side effects during and after chemotherapy in retinoblastoma patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinoblastoma', 'topotecan', 'Melphalan'], 'conditions': ['Retinoblastoma', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.', 'detailedDescription': 'To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as retinoblastoma\n* receiving eyeball-sparing treatment\n\nExclusion Criteria:\n\n* disease progression during follow-up'}, 'identificationModule': {'nctId': 'NCT04799002', 'briefTitle': 'Topotecan and Melphalan for Retinoblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Choice of Topotecan or Melphalan in Retinoblastoma Patients', 'orgStudyIdInfo': {'id': '202103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topotecan', 'description': 'Topotecan intraocular injection during chemotherapy', 'interventionNames': ['Drug: Topotecan']}, {'type': 'EXPERIMENTAL', 'label': 'Melphalan', 'description': 'Melphalan intraocular injection during chemotherapy', 'interventionNames': ['Drug: Melphalan']}], 'interventions': [{'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Topotecan intraocular injection'], 'description': 'Topotecan intraocular injection for chemotherapy in retinoblastoma', 'armGroupLabels': ['Topotecan']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Melphalan intraocular injection'], 'description': 'Melphalan intraocular injection for chemotherapy in retinoblastoma', 'armGroupLabels': ['Melphalan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijing Ye, Doctor', 'role': 'CONTACT', 'email': 'yehuijing@qq.com', 'phone': '00862087331539'}, {'name': 'Huasheng Yang, Doctor', 'role': 'CONTACT', 'email': 'yanghs64@126.com', 'phone': '00862087331539'}], 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Huasheng Yang', 'role': 'CONTACT', 'email': 'yanghs64@126.com', 'phone': '+00862087331539'}, {'name': 'Huijing Ye', 'role': 'CONTACT', 'email': 'yehuijing@qq.com', 'phone': '+00862087331539'}], 'overallOfficials': [{'name': 'Huashen Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huasheng Yang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}