Bladder (Urothelial, Transitional Cell) Cancer
Conditions
Keywords
Non-Muscle Invasive Bladder Cancer, Intravesical Therapy, Non-Surgical Treatment
Brief summary
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.
Detailed description
In this study, patients with histologically confirmed Ta low-grade bladder cancer will undergo chemoablation with gemcitabine (six weekly instillations). The study aims to evaluate the efficacy, safety, and tolerability of chemoablation.
Interventions
DRUGGemcitabine
Intravesical installation
Sponsors
Ekaterina Laukhtina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical complete response (cCR) | From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment). | cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment). | pCR defined as negative urine cytology, absence of macroscopic tumor at cystoscopic evaluation and confirmed by negative biopsy/TURB |
| Patient-reported Outcomes based on EORTC QLQ-NMIBC24 | Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment). | The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-NMIBC24 questionnaire. |
| Patient-reported Outcomes based on EORTC QLQ-C30 | Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment). | The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-C30 questionnaire. |
Countries
Austria
Contacts
Primary ContactEkaterina Laukhtina Dr., Medical Doctor
Outcome results
None listed