Chemoablation for Low-Grade Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEkaterina Laukhtina
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Tumors that clinicians suspect to be HG
Positive HG cytology according to Paris criteria
Diameter of tumor >15 mm
Number of lesions >5
Trial design
Treatments tested in this trial
- Gemcitabine
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Ekaterina Laukhtina
Lead sponsor
Medical University of Vienna
Sponsor institution
Source ClinicalTrials.gov