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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Gemcitabine
DrugIntravesical installation
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: Patients with low-grade NMIBCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical complete response (cCR)
cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation
Time frame
From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).Secondary outcomes
1
Pathological complete response (pCR)
pCR defined as negative urine cytology, absence of macroscopic tumor at cystoscopic evaluation and confirmed by negative biopsy/TURB
Time frame
From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).2
Patient-reported Outcomes based on EORTC QLQ-NMIBC24
The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-NMIBC24 questionnaire.
Time frame
Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).3
Patient-reported Outcomes based on EORTC QLQ-C30
The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-C30 questionnaire.
Time frame
Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ekaterina Laukhtina
Lead sponsor
Medical University of Vienna
Sponsor institution
Source ClinicalTrials.gov