Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-22 @ 8:06 PM
Study NCT ID:
NCT06167057
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POST URS Chemotherapy Instillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, double arm, single blinded randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 year IVR free survival', 'timeFrame': '1 year', 'description': 'no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year'}], 'secondaryOutcomes': [{'measure': '2 years IVR free survival', 'timeFrame': '2 years', 'description': 'no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year'}, {'measure': 'Disease free survival', 'timeFrame': '2 years'}, {'measure': 'High grade (>3) adverse events', 'timeFrame': '2 years', 'description': 'Adverse events that are severe or medically significant but not immediately life threatening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnostic URS', 'single-dose chemotherapy bladder instillation', 'IVR'], 'conditions': ['UTUC']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.\n\nParticipants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.', 'detailedDescription': 'URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function.\n\nFollowing extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU.\n\nRetrospective evidence suggests there is an increase IVR rates following URS for UTUC.\n\nIn this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiographic and/or cytological suspicion for UTUC\n* Planned endoscopic procedure for treatment / diagnosis of UTUC\n* Patients with bladder cancer history are eligible if meeting both following criteria:\n\nNo recurrence within the last two years Are not on active bladder irrigation protocol\n\n* Patients with history of UTUC are eligible if last endoscopic treatment or RNU was \\>1 year prior to enrollment\n* Age ≥ 18 years\n* Performance status ECOG 0-2\n\nExclusion Criteria:\n\n* Subjects who have had bladder / prostate radiotherapy\n* Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment\n* Subjects with previously treated UTUC within one year prior to enrollment\n* Subjects with metastatic disease'}, 'identificationModule': {'nctId': 'NCT06167057', 'briefTitle': 'POST URS Chemotherapy Instillation', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence', 'orgStudyIdInfo': {'id': '0154-22-CMC-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation', 'interventionNames': ['Drug: Mitomycin/Gemcitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Single post-operative 50cc Saline 0.9% bladder instillation', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Mitomycin/Gemcitabine', 'type': 'DRUG', 'description': 'UTUC treatment', 'armGroupLabels': ['A']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'UTUC treatment', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ashdod', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dor Golomb, Dr', 'role': 'CONTACT', 'email': 'golombdor@gmail.com'}], 'facility': 'Assuta Ashdod Hospital', 'geoPoint': {'lat': 31.79213, 'lon': 34.64966}}, {'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jonathan Wagmaister, Dr', 'role': 'CONTACT', 'email': 'jonathanwa@clalit.org.il'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Be’er Ya‘aqov', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amnon Zisman, Prof', 'role': 'CONTACT', 'email': 'AmnonZ@shamir.gov.il'}], 'facility': 'Shamir Medical Center', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}, {'zip': '31048', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Zaher Bahouth, Dr', 'role': 'CONTACT', 'email': 'zaher.bahouth@gmail.com'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yuval Freifeld, Dr.', 'role': 'CONTACT', 'email': 'Yuvalfr@clalit.org.il'}, {'name': 'Yuval Freifeld, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Michael Mullerad, Dr', 'role': 'CONTACT', 'email': 'M_MULLERAD@rambam.health.gov.il'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4937211', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David Lifshitz, Prof', 'role': 'CONTACT', 'email': 'davidlif@clalit.org.il'}], 'facility': 'Rabin Medical Center - Beilinson and Hasharon', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rehovot', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yaniv Shilo, Dr', 'role': 'CONTACT', 'email': 'MRYANIVSH@clalit.org.il'}], 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Safed', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ran Katz, Dr', 'role': 'CONTACT', 'email': 'rank@ziv.gov.il'}], 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ziv Savin, Dr', 'role': 'CONTACT', 'email': 'zivsavin23@gmail.com'}], 'facility': 'Tel Aviv Sourasky Medical Center - Ichilov', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Yuval Freifeld, Dr', 'role': 'CONTACT', 'email': 'yuvalfr@clalit.org.il', 'phone': '+972-4-8250843'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Urologic-Oncology unit, Carmel Medical Center', 'investigatorFullName': 'Yuval Freifeld', 'investigatorAffiliation': 'Carmel Medical Center'}}}}