Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-17 @ 4:44 PM
Study NCT ID:
NCT03058757
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.', 'timeFrame': '1 year', 'description': 'Pathologic recurrence free survival after transurethral resection'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan.', 'timeFrame': '1 years', 'description': 'Pathologic or radiologi progression free survival after transurethral resection'}, {'measure': 'Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.', 'timeFrame': '1 years', 'description': 'Period of from transurethral resection to first pathologic recurrence'}, {'measure': 'Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. Change of tumor size will be assessed by CT scan and cystoscopic exam.', 'timeFrame': '1 years', 'description': 'Change of tumor size at the time point of diagnostic cystoscope to transurethral resection'}, {'measure': 'Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.', 'timeFrame': 'six years', 'description': 'Safety will be assessed by International Prostate Symptom Score (IPSS; 0-7, mildly symptomatic; 8-19, moderately symptomatic; 20-35 severely symptomatic) and treatment delay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients', 'detailedDescription': 'Study Design: Intervention Model: Single Group Assignment Masking: Open Label\n\nPrimary Outcome Measures:\n\nRecurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.\n\nSecondary Outcome Measures:\n\nProgression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.\n\nTime to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.\n\nChange of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.\n\nSafety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects who will undergo transurethral resection of the tumor after diagnosis of bladder cancer\n* Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as bladder cancer\n* Normal bone marrow function: Hemoglobin \\>10 g/dL, ANC \\>1,500/mm3, platelet count\\>100,000/mm3\n* Normal renal function: serum creatinine ≤ 1.4 mg/dL\n* Normal liver function:\n* Bilirubin ≤ 1.5 times of upper normal limit\n* AST/ALT ≤ 1.8 times of upper normal limit\n* Alkaline phosphatase ≤ 1.8 times of upper normal limit\n* Subjects who voluntarily decided to participate and signed the written informed consent\n\nExclusion Criteria:\n\n* Non-urothelial carcinoma\n* Muscle invasive bladder cancer\n* Subjects who underwent intravesical mitomycin-C instillation after diagnosis of bladder cancer within 3 years\n* Prior hypersensitivity reaction history to mitomycin-C\n* Neurogenic bladder\n* Subjects who underwent chemotherapy due to any cancer within 6 months'}, 'identificationModule': {'nctId': 'NCT03058757', 'briefTitle': 'The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study', 'orgStudyIdInfo': {'id': 'NeoadjMitomycin-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'No intervention applied.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'neoadjuvant intravesical mitomycin-C 40mg/20ml instillation', 'interventionNames': ['Drug: intravesical mitomycin-C 40mg/20ml instillation']}], 'interventions': [{'name': 'intravesical mitomycin-C 40mg/20ml instillation', 'type': 'DRUG', 'otherNames': ['Mitomycin_C Kyowa'], 'description': 'neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation\n\n* one day before surgery\n* four hours before surgery', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}], 'overallOfficials': [{'name': 'Ho Kyung Seo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Ho Kyung Seo', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}