Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-11 @ 12:26 AM
Study NCT ID:
NCT01697306
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive 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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D001500', 'term': 'BCG Vaccine'}, {'id': 'C087507', 'term': 'BCG Connaught'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'comparison of the short term efficacy of the two treatments in terms of recurrence', 'timeFrame': '1 year'}, {'measure': 'comparison of the short term efficacy of the two treatments in terms of progression', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non muscle invasive bladder cancer'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '16145378', 'type': 'BACKGROUND', 'citation': 'Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, Rodriguez RH, Gomez JM, Martin MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadan M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urologico Espanol de Tratamiento Oncologico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. doi: 10.1097/01.ju.0000173919.28835.aa.'}, {'pmid': '20173364', 'type': 'BACKGROUND', 'citation': 'Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guerin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.', 'detailedDescription': 'Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, \\>3 cm in diameter)\n* WHO performance status ≤2\n* age ≤85years\n* BCG naive\n* patients not treated with intravesical chemotherapy in the last 3 months.\n\nExclusion Criteria:\n\n* presence of T1G3 or CIS\n* preoperative urinary cytology positive for high-grade atypia\n* inadequate bone marrow reserve (white blood cells \\<3 x 109/l, platelets \\<100 x 109/l)\n* history of genito-urinary tuberculosis\n* presence of uncontrolled urinary infections.'}, 'identificationModule': {'nctId': 'NCT01697306', 'briefTitle': 'The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.', 'orgStudyIdInfo': {'id': 'CE 70/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine-arm', 'description': '7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year', 'interventionNames': ['Drug: Gemcitabine 2 g']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BCG-arm', 'description': '7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months', 'interventionNames': ['Drug: BCG Vaccine']}], 'interventions': [{'name': 'Gemcitabine 2 g', 'type': 'DRUG', 'otherNames': ['Gemzar, Eli Lilly SpA'], 'description': 'six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline', 'armGroupLabels': ['Gemcitabine-arm']}, {'name': 'BCG Vaccine', 'type': 'DRUG', 'otherNames': ['BCG Connaught 1/3 dose'], 'description': 'six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline', 'armGroupLabels': ['BCG-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'A.O.U. San Giovanni Battista Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Paolo Gontero, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. San Giovanni Battista Molinette'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turin, Italy', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'University of Eastern Piedmont', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marco Oderda', 'investigatorAffiliation': 'Azienda Ospedaliera San Giovanni Battista'}}}}