Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT06388720
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High risk Recurrent free survival in sequential treatment group.', 'timeFrame': '1year', 'description': 'Time from initial TURBT\\* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival in sequential treatment group.', 'timeFrame': '1year', 'description': 'defined as the period from the initial TURBT date\\* to the time when T stage progresses (e.g., Ta\\>T1, CIS\\>T1) (PFS1) or muscle invasive bladder cancer (T2 or higher) was first biopsy confirmed (PFS2) or imagingally diagnosed with metastasis to bladder cancer.'}, {'measure': 'Cystectomy free survival in sequential treatment group.', 'timeFrame': '1year', 'description': 'Defined as the period from the initial TURBT date\\* to the time when radical cystomy was performed.'}, {'measure': 'cancer specific survival in sequential treatment group.', 'timeFrame': '1year', 'description': 'Duration from initial TURBT date\\* to the time of death from bladder cancer'}, {'measure': 'Overall survival in sequential treatment group.', 'timeFrame': '1year', 'description': 'The period from the initial TURBT date\\* to the point of death (regardless of cause)'}, {'measure': 'Safety of sequential treatment.', 'timeFrame': '2year', 'description': 'The first safety analysis is conducted on test subjects who have developed toxicity in accordance with CTCAE standards. In particular, urinary disorders such as urinary tract infections and acute urination that occurred after injection of drugs into the bladder are evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high risks non-muscle invasive bladder cancer', 'Sequential treatment', 'Intravesical treatment', 'Mitomycin-c', 'Gemcitanine'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.', 'detailedDescription': 'Phase 2 clinical, multi-institutional, open assignment prospective study\n\nPrimary Outcome Measures:\n\n1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.\n\nSecondary Outcome Measures:\n\nProgression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a patient over the age of 20\n2. Patients who are willing and able to complete a written test subject consent/approval for this examination.\n3. Patients with histological confirmation of high-risk non-muscle infiltration (T1, high-grade Ta and/or CIS) bladder transition cell cancer. However, according to the definition of EAU guidelines high-risk NMIBC, Ta, low grade, and multiple recurrences of more than 3 cm are included.\n4. The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG\n5. Patients who are not eligible for a radical bladder resection or who have refused surgery.\n6. Patient who are not being pregnant or breast feeding until the study period.\n\nExclusion Criteria:\n\n1. Patient diagnosed with muscle-invasive bladder cancer at TURBT\n2. If upper urinary tract urothelial cancer is accompanied by imaging\n3. If the imaging indicates extravesical involvement (cT3)\n4. Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis\n5. In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma)\n6. In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years\n7. If patient have a history of pelvic radiation therapy for other cancers within 3 years\n8. If patient have a history of receiving Mitomycin-c or gemcitabine in the bladder within 3 years. The exception is cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer\n9. If patient has a history of allergy to mitomycin-c or gemcitabine\n10. Cystoscopy shows a tumor in the prostate urethra\n11. Patients who have participated in studies using clinical trial drugs and are currently receiving clinical trial drugs or who have used clinical trial drugs or clinical trial medical devices within 4 weeks prior to the date of initial treatment\n12. After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment\n13. Thrombocytopenia, coagulopathy or bleeding tendency patient.\n14. Pregnant or breast-feeding women\n15. If patient treated yellow fever vaccine or phenytoin\n16. Dysfunction of liver or kidney (GFP≤30)\n17. If patient undergo severe myelosuppression\n18. If patient complicated severe infection\n19. If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.\n20. If patient conduct chest radiotherapy.'}, 'identificationModule': {'nctId': 'NCT06388720', 'acronym': 'IMGeS', 'briefTitle': 'The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy', 'orgStudyIdInfo': {'id': 'NCC2024-0026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml', 'interventionNames': ['Drug: Mitomycin-C', 'Drug: gemcitabine']}], 'interventions': [{'name': 'Mitomycin-C', 'type': 'DRUG', 'otherNames': ['Sequential treatment group'], 'description': 'Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.', 'armGroupLabels': ['Intervention group']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': 'Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Kyung Seo', 'role': 'CONTACT', 'email': 'seohk@ncc.re.kr', 'phone': '82-31-920-1678'}, {'name': 'Ho Kyung Seo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eui Hyun Jung, Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Ho Kyung Seo, MD', 'role': 'CONTACT', 'email': 'seohk@ncc.re.kr', 'phone': '82-31-920-1678'}, {'name': 'Eui Hyun Jung, Ph.D', 'role': 'CONTACT', 'email': 'jeh0315@ncc.re.kr', 'phone': '82-31-920-2451'}], 'overallOfficials': [{'name': 'Ho Kyung Seo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, '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'}}}}