Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-10 @ 9:48 PM
Study NCT ID:
NCT02547350
Status:
UNKNOWN
Last Update Posted:
2015-09-11
First Post:
2015-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'C027260', 'term': 'pirarubicin'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2015-09-08', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intravesical recurrence-free survival', 'timeFrame': 'two years after surgery'}], 'secondaryOutcomes': [{'measure': 'cancer-specific survival', 'timeFrame': 'two years after surgery'}]}, 'conditionsModule': {'conditions': ['Upper Tract Urothelial Carcinoma', 'Bladder Recurrence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who were clinically diagnosed with UTUC\n2. Treated with radical nephroureterectomy\n\nExclusion Criteria:\n\n1. Distant metastasis\n2. Prior history of bladder or synchronous bladder cancer\n3. Administration of neoadjuvant chemotherapy\n4. Presence of severe complications.'}, 'identificationModule': {'nctId': 'NCT02547350', 'briefTitle': 'Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'orgStudyIdInfo': {'id': 'PIC-UTUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Blank control', 'description': 'do not use prophylactic intravesical chemotherapy'}, {'type': 'EXPERIMENTAL', 'label': 'single intravesical instillation', 'description': 'intravesical instillation within 24 hours postoperatively', 'interventionNames': ['Drug: pharmorubicin or pirarubicin']}, {'type': 'EXPERIMENTAL', 'label': 'multiple intravesical instillation', 'description': 'intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months', 'interventionNames': ['Drug: pharmorubicin or pirarubicin']}], 'interventions': [{'name': 'pharmorubicin or pirarubicin', 'type': 'DRUG', 'description': 'pharmorubicin 50mg pirarubicin 30mg', 'armGroupLabels': ['multiple intravesical instillation', 'single intravesical instillation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuesong Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xuesong Li', 'investigatorAffiliation': 'Peking University First Hospital'}}}}