Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-18 @ 1:34 PM
Study NCT ID:
NCT03030157
Status:
UNKNOWN
Last Update Posted:
2019-10-09
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
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': 'C027260', 'term': 'pirarubicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of bladder cancer in the first 12 month following nephroureterectomy', 'timeFrame': '12 month', 'description': 'Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '2 day, 1 month and 12 month'}, {'measure': 'questionnaire for quality of life', 'timeFrame': 'baseline, 1 month and 12 month', 'description': 'e.g QLQ C-30'}, {'measure': 'progression-free survival', 'timeFrame': '12 month', 'description': 'progression-free survival'}, {'measure': 'cancer-specific survival', 'timeFrame': '12 month', 'description': 'cancer-specific survival'}, {'measure': 'overall survival', 'timeFrame': '12 month', 'description': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urothelial cancer', 'bladder cancer', 'nephroureterectomy'], 'conditions': ['Intravesical Instillation']}, 'descriptionModule': {'briefSummary': 'Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically diagnosed with upper tract urothelial carcinoma\n* have no distant metastasis\n* have an ECOG 0 to 2\n* expected to receive radical nephroureterectomy\n\nExclusion Criteria:\n\n* a prior history of bladder or synchronous bladder cancer\n* administration of neoadjuvant chemotherapy\n* the presence of severe complications\n* deny to receive cytoscopy\n* patients with advanced stage (T4)\n* patients with contralateral UTUCs'}, 'identificationModule': {'nctId': 'NCT03030157', 'briefTitle': 'Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'RenJiH-PDU Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-term Intravesical Instillation of pirarubicin(THP)', 'description': 'A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.', 'interventionNames': ['Drug: pirarubicin(THP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single Intravesical Instillation of pirarubicin', 'description': 'A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.', 'interventionNames': ['Drug: pirarubicin(THP)']}], 'interventions': [{'name': 'pirarubicin(THP)', 'type': 'DRUG', 'armGroupLabels': ['Long-term Intravesical Instillation of pirarubicin(THP)', 'Single Intravesical Instillation of pirarubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jiwei huang, M.D', 'role': 'CONTACT', 'email': 'jiweihuang@outlook.com', 'phone': '8613651682825'}, {'name': 'jin zhang', 'role': 'CONTACT', 'email': 'zhangjin@renji.com', 'phone': '86-21-68383776'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'jiwei huang', 'role': 'CONTACT', 'email': 'jiweihuang@outlook.com', 'phone': '8613651682825'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pudong Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Pudong New Area Gongli Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Urology department in Renji Hospital', 'investigatorFullName': 'Yiran Huang', 'investigatorAffiliation': 'RenJi Hospital'}}}}