Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 7:53 PM
Study NCT ID:
NCT03209206
Status:
UNKNOWN
Last Update Posted:
2017-12-22
First Post:
2017-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder 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': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Phase II Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence in bladder', 'timeFrame': '2years', 'description': 'Present of bladder recurrence after intervention in follow up cystoscopy or CT scan'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '2years', 'description': 'Present of adverse event after intervention'}, {'measure': 'Overall Survival', 'timeFrame': '2years', 'description': 'Overall Survival rate during follow up period'}, {'measure': 'Time to recurrence', 'timeFrame': '2years', 'description': 'Time to bladder recurrence after intervention in follow up cystoscopy or CT scan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravesical Chemotherapy', 'Docetaxel', 'Radical Nephroureterectomy'], 'conditions': ['Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23460707', 'type': 'RESULT', 'citation': 'Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial. J Clin Oncol. 2013 Apr 10;31(11):1422-7. doi: 10.1200/JCO.2012.45.2128. Epub 2013 Mar 4.'}, {'pmid': '23563166', 'type': 'RESULT', 'citation': 'Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. doi: 10.18632/oncotarget.852.'}, {'pmid': '26537069', 'type': 'RESULT', 'citation': 'Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic review and meta-analysis. J BUON. 2015 Sep-Oct;20(5):1229-38.'}, {'pmid': '19913890', 'type': 'RESULT', 'citation': 'Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010 Jan;75(1):134-7. doi: 10.1016/j.urology.2009.06.112. Epub 2009 Nov 13.'}, {'pmid': '25772330', 'type': 'RESULT', 'citation': 'Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13.'}, {'pmid': '19389012', 'type': 'RESULT', 'citation': 'Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guerin therapy. BJU Int. 2009 Oct;104(8):1098-102. doi: 10.1111/j.1464-410X.2009.08543.x. Epub 2009 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).', 'detailedDescription': 'Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.\n\nIn this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upper urinary tract urothelial cell carcinoma\n* Hb\\>10g/dL, ANC \\>1500mm3, Platelet \\> 100K\n* Total bilirubin : 1.5 times lower than the normal upper limit\n* AST/ALT: 1.8 times lower than the normal upper limit\n* Alkaline phosphatase: 1.8 times lower than the normal upper limit\n\nExclusion Criteria:\n\n* Concomitant bladder tumor\n* Patients diagnosed with bladder cancer within the last 3 years\n* Previous history of hypersensitivity to Docetaxel\n* Neurogenic Bladder\n* Patients who received chemotherapy for cancer within the last 6 months\n* Patients with active disease not fit for this study\n* ANC \\<1500mm3\n* Pregnant or lactating women\n* Patients with severe hepatic dysfunction\n* patients with severe renal impairment\n* patients with hypersensitivity to mannitol, paraplatin, platinum compounds\n* Patients with complications of infection\n* Patients suspected of having infectious fever'}, 'identificationModule': {'nctId': 'NCT03209206', 'briefTitle': 'The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study', 'orgStudyIdInfo': {'id': 'SeoulNUHUro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel bladder instillation arm', 'description': 'After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)', 'interventionNames': ['Drug: Docetaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)', 'interventionNames': ['Drug: Placebo Normal saline']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Instillation docetaxel after radical nephroureterectomy'], 'description': 'Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)', 'armGroupLabels': ['Docetaxel bladder instillation arm']}, {'name': 'Placebo Normal saline', 'type': 'DRUG', 'otherNames': ['Instillation Normal saline after radical nephroureterectomy'], 'description': 'Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ja Hyeon Ku, M.D, Ph.D', 'role': 'CONTACT', 'email': 'randyku@hanmail.net', 'phone': '82-2-2072-0361'}, {'name': 'Bum Sik Tae, M.D', 'role': 'CONTACT', 'email': 'bumsik4ever@hanmail.net', 'phone': '82-2-2072-0361'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ja Hyeon Ku, M.D.,PH.D', 'role': 'CONTACT', 'email': 'randyku@hanmail.net', 'phone': '+82-2-2072-0361'}, {'name': 'Bum Sik Tae, M.D', 'role': 'CONTACT', 'email': 'bumsik4ever@hanmail.net', 'phone': '+82-10-9056-6618'}], 'overallOfficials': [{'name': 'Ja Hyeon Ku, M.D.,PH.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD., PHD.', 'investigatorFullName': 'Ja Hyeon Ku', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}