Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-29 @ 4:43 PM
Study NCT ID:
NCT04481100
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-17', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '4-8 weeks', 'description': 'ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1'}], 'secondaryOutcomes': [{'measure': 'Treatment-emergent adverse events', 'timeFrame': 'year 0 - year 1', 'description': 'Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion.'}, {'measure': 'Local-regional free survival (LRFS)', 'timeFrame': 'year 0 - year 3', 'description': 'LRFS was calculated from the date of treatment initiation to the date of documented failure.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'year 0 - year 3', 'description': 'OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal Squamous Cell Carcinoma', 'Concurrent chemoradiotherapy', 'Itraconazole', 'Hedgehog pathway'], 'conditions': ['Esophageal Neoplasm', 'Esophageal Diseases', 'Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer', 'detailedDescription': 'Esophageal cancer is one of the most lethal malignancies. Esophageal squamous cell carcinoma (ESCC) is the predominant type in China, accounting for over 90% of all esophageal cancer. Concurrent chemoradiation therapy (CCRT) remains the standard therapy of locally advanced ESCC. However, the outcome remains poor.\n\nThe aberrant activation of Hedgehog (HH) signaling is associated with a variety of human malignancies. Previous studies found that the reactivation of HH pathway occurs in 60% of esophageal cancer. Targeting the Hh pathway for cancer therapy was expected to work wonders in Hh-dependent cancers. Itraconazole, an antifungal agent, has been shown to inhibit the Hh and AKT signaling pathways.\n\nThe aim of our study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage:18-75 years, male or femal.\n\nHistologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.\n\nClinical staged T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa(AJCC 8th)\n\nMeasurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n\nECOG 0-1.\n\nAdequate organ function.\n\nPatient has given written informed consent.\n\nExclusion Criteria:\n\nUnwilling or unable to provide informed consent\n\nKnown allergy to itraconazole\n\nPatients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.\n\nComplete obstruction of the esophagus, or patients who have the potential to develop perforation, or unable to swallow Itraconazole.\n\nOther malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.\n\nHas received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.\n\nPregnancy or breast-feeding.\n\nDecision of unsuitableness by principal investigator or physician-in-charge.'}, 'identificationModule': {'nctId': 'NCT04481100', 'briefTitle': 'CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Cancer Hospital'}, 'officialTitle': 'Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer', 'orgStudyIdInfo': {'id': '20200707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.', 'interventionNames': ['Drug: itraconazole']}], 'interventions': [{'name': 'itraconazole', 'type': 'DRUG', 'description': 'Oral administration of itraconazole twice daily concurrent with chemoradiation', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518116', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shixiu Wu, phD', 'role': 'CONTACT', 'email': 'wushixiu@medmail.com.cn', 'phone': '+8675566618168'}], 'facility': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Shixiu Wu, phD', 'role': 'CONTACT', 'email': 'wushixiu@medmail.com.cn', 'phone': '86-755-66618168'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shixiu Wu', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}