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New treatment option for Bladder (Urothelial, Transitional Cell) Cancer
Official title Chemoablation for Low-Grade Bladder Cancer
ClinicalTrials.gov ID: NCT07019220
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bladder (urothelial, transitional cell) cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
- 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...
- 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
You likely can't join if
- Tumors that clinicians suspect to be HG
- 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.
See the full eligibility criteria
- Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
- 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
- Tumors that clinicians suspect to be HG
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.