Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03062059
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.', 'timeFrame': 'Two years', 'description': 'Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.', 'timeFrame': 'six years', 'description': 'Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence'}, {'measure': 'Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.', 'timeFrame': 'six years', 'description': 'Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine'}, {'measure': 'CT cystography finding at one week after surgery.', 'timeFrame': 'one week', 'description': 'Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine'}, {'measure': 'International Prostate Symptom Score questionnaire at one week after surgery.', 'timeFrame': 'one week', 'description': 'Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.', 'detailedDescription': 'Study Design: Intervention Model: Single Group Assignment\n\nMasking: Open Label\n\nPrimary Outcome Measures:\n\nTwo year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.\n\nSecondary Outcome Measures:\n\nTime to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.\n\nOverall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.\n\nSafety of intravesical 2000mg/52.6ml gemcitabine 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 nephroureterectomy due to ureter or renal pelvis urothelial carcinoma\n* Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as upper urinary tract urothelial carcinoma\n* Normal bone marrow function: Hemoglobin \\>10 g/dL, ANC \\>1,500/mm3, platelet count\\>100,000/mm3\n* Normal bladder volume and function\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* Concomitant bladder cancer\n* Subjects who underwent any treatment due to bladder cancer within 3 years\n* Prior hypersensitivity reaction history to gemcitabine\n* Neurogenic bladder\n* Subjects who underwent chemotherapy due to any cancer within 6 months\n* Subjects who underwent neoadjuvant chemotherapy due to ureter or renal pelvis urothelial carcinoma\n* Hypersensitivity to gemcitabine or component of gemcitabine\n* In case of co-administration of gemcitabine and cisplatin in severe renal failure patients\n* Moderate to severe liver dysfunction or renal dysfunction (Glomerular filtration rate \\< 30 mL/min)\n* Severe bone marrow suppression\n* Severe infection\n* Female who are pregnant or has a possibility of pregnancy\n* Nursing female\n* Interstitial pneumonia or pulmonary fibrosis which is evident on chest x-ray and symptomatic\n* Subjects who are undergoing radiotherapy on chest'}, 'identificationModule': {'nctId': 'NCT03062059', 'briefTitle': 'The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study', 'orgStudyIdInfo': {'id': 'InstiGem'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Intravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation', 'interventionNames': ['Other: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcitabine', 'description': 'Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation', 'interventionNames': ['Drug: Intravesical 2000mg/52.6ml gemcitabine instillation']}], 'interventions': [{'name': 'Intravesical 2000mg/52.6ml gemcitabine instillation', 'type': 'DRUG', 'otherNames': ['Gem Tan inj (liquid)'], 'description': 'Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma', 'armGroupLabels': ['Gemcitabine']}, {'name': 'Normal saline', 'type': 'OTHER', 'description': 'Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Kyung Seo, M.D.', 'role': 'CONTACT'}, {'name': 'Jinsoo Chung, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sung Han Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bum Sik Hong, M.D.', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seok Ho Kang, M.D.', 'role': 'CONTACT'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byong Chang Jeong, M.D.', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ja Hyun Ku, M.D.', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ho Kyung Seo, M.D.', 'role': 'CONTACT', 'email': 'seohk@ncc.re.kr', 'phone': '82-31-920-1678'}, {'name': 'Yoon Seok Suh, M.D.', 'role': 'CONTACT', 'email': '12754@ncc.re.kr', 'phone': '82-10-5019-9807'}], 'overallOfficials': [{'name': 'Seok Ho Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea universitiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Chong Kun Dang Pharmaceutical Corp.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Ho Kyung Seo', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}