Gemcitabine chemoablation for low-grade bladder cancer
COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study
This study will try weekly bladder instillations of the chemotherapy drug gemcitabine to remove or control small, low-grade (Ta) bladder tumors in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07019220 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, prospective, open-label Phase 2 study that gives six weekly intravesical instillations of gemcitabine to adults with histologically confirmed Ta low-grade bladder cancer. Eligible participants may have up to five tumors with the largest lesion ≤15 mm and must have negative cytology for high-grade disease and no metastases. The protocol collects cystoscopic and cytologic outcomes to measure local tumor response and monitors safety and tolerability throughout follow-up. The approach aims to determine whether chemoablation can clear or control small low-grade lesions and potentially reduce the need for transurethral resection.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed recurrent or primary Ta low-grade bladder cancer, up to five lesions with the largest ≤15 mm, negative high-grade cytology, and no lymph node or distant metastasis are the intended participants.
Not a fit: Patients with high-grade or muscle-invasive disease, more than five lesions, tumors larger than 15 mm, positive cytology for high-grade disease, or evidence of nodal or distant metastases are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, intravesical gemcitabine chemoablation could clear small low-grade bladder tumors without surgery, reducing procedural risks and recovery time.
How similar studies have performed: Smaller and observational studies of intravesical gemcitabine and chemoablation strategies have shown promising but not definitive results for low-grade non–muscle-invasive bladder cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vienna
- Department of Urology, Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Shahrokh F. Shariat Prof. Dr., Professor — Department of Urology, Medical University of Viernna
- Study coordinator: Ekaterina Laukhtina Dr., Medical Doctor
- Email: ekaterina.laukhtina@meduniwien.ac.at
- Phone: +43 (0)1 40400-26315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.