GEMCITABINE HYDROCHLORIDE for Bladder cancer | Non-muscle invasive bladder cancer (Ta low-grade)

Inclusion criteria

• {"criterion_text":"- 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\n- 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\n- Willing and able to provide informed consent\n- On screening cystoscopy: Diameter of the largest lesion ≤15mm\n- Number of lesions ≤5\n- Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation\n- Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)\n- NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)\n- Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening\n- No lymph node metastasis or distant metastasi\n- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment"}

Exclusion criteria

• {"criterion_text":"- Tumors that clinicians suspect to be HG\n- History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding\n- 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\n- Patient refused to participate\n- Positive human immunodeficiency virus (HIV) test\n- Female patients who are pregnant/breastfeeding\n- Female patients of childbearing potential not using adequate contraception\n- Positive HG cytology according to Paris criteria\n- Diameter of tumor >15 mm\n- Number of lesions >5\n- Any previous intravesical therapy within 1 year\n- 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\n- Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC\n- History of upper tract urothelial carcinoma (UTUC)\n- Clinically significant urethral stricture that would preclude passage of a urethral catheter"}

Primary endpoints

• {"endpoint_text":"- Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation)","definition_or_measurement_approach":"cCR defined as absence of the macroscopic tumor after chemoablation (as stated in the endpoint text)"}

Secondary endpoints

• {"endpoint_text":"- Pathological complete response (pCR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall response (cCR + pCR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0)","definition_or_measurement_approach":"Adverse events evaluated using NCI CTCAE v5.0"}
• {"endpoint_text":"- Rate of treatment discontinuation (at least 5 from 6 instillations within 8 weeks)","definition_or_measurement_approach":"Discontinuation defined as receiving fewer than 5 of 6 instillations within an 8-week period (as stated)"}
• {"endpoint_text":"- Health-related quality of life","definition_or_measurement_approach":""}

Austria

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

23

Number Of Sites

1

Number Of Participants

47

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria