Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
47 participants
INTERVENTIONAL
2023-12-27
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with low-grade NMIBC
Gemcitabine
Intravesical installation
Interventions
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Gemcitabine
Intravesical installation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening
* On screening cystoscopy: Diameter of the largest lesion ≤15mm
* Number of lesions ≤5
* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
* No lymph node metastasis or distant metastasis
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
* Willing and able to provide informed consent
Exclusion Criteria
* Positive HG cytology according to Paris criteria
* Diameter of tumor \>15 mm
* Number of lesions \>5
* Any previous intravesical therapy within 1 year
* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.
* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
* History of upper tract urothelial carcinoma (UTUC)
* Clinically significant urethral stricture that would preclude passage of a urethral catheter
* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
* Patient refused to participate
* Known positive human immunodeficiency virus (HIV) test.
* Female patients who are pregnant/breastfeeding.
* Female patients of childbearing potential not using adequate contraception.
18 Years
ALL
No
Sponsors
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Ekaterina Laukhtina
OTHER
Responsible Party
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Ekaterina Laukhtina
Dr.
Principal Investigators
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Shahrokh F. Shariat Prof. Dr., Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Medical University of Viernna
Locations
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Department of Urology, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Brausi MA, Gontero P, Altieri V, Colombo R, Conti I, Bono AV. Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study. Urol Int. 2011;87(4):470-4. doi: 10.1159/000331727. Epub 2011 Nov 11.
Gardmark T, Carringer M, Beckman E, Malmstrom PU; Members of the Intravesical Gemcitabine Study Group. Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder. Urology. 2005 Sep;66(3):527-30. doi: 10.1016/j.urology.2005.03.084.
Maffezzini M, Campodonico F, Canepa G, Capponi G, Fontana V. Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder. Eur Urol. 2007 Apr;51(4):956-61. doi: 10.1016/j.eururo.2006.08.038. Epub 2006 Sep 20.
Campodonico F, Canepa G, Capponi G, Bozzo L, Maffezzini M. Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability. Anticancer Res. 2005 May-Jun;25(3c):2381-4.
Serretta V, Galuffo A, Pavone C, Allegro R, Pavone-MacAluso M. Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions. Urology. 2005 Jan;65(1):65-9. doi: 10.1016/j.urology.2004.08.027.
Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol. 2004 Sep;46(3):339-43. doi: 10.1016/j.eururo.2004.05.001.
Other Identifiers
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COBRA
Identifier Type: -
Identifier Source: org_study_id
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