Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study.
Maurizio A Brausi, Paolo Gontero, Vincenzo Altieri...
https://pubmed.ncbi.nlm.nih.gov/22086229Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07019220
COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label Phase 2 Study
Led by Ekaterina Laukhtina · Updated on 2025-06-13
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravesical chemoablation with gemcitabine in patients who have low-grade bladder cancer confirmed by biopsy. This open-label Phase 2 clinical trial aims to assess the treatment's effectiveness, safety, and tolerability in this patient group. The study focuses on patients with recurrent or primary Ta low-grade bladder cancer who meet specific tumor size and lesion number limits. Participants will receive six weekly instillations of gemcitabine directly into the bladder. This treatment approach is designed to treat the bladder cancer locally without surgery. The study includes a single treatment arm with no placebo or comparator group. The treatment period will be followed by monitoring to evaluate responses and side effects. Throughout the study, patients will undergo cystoscopy and bladder examinations, including photo documentation of tumors, to assess clinical and pathological responses at the end of treatment and during follow-up visits at 1 and 3 months post-treatment. Patient-reported outcomes on quality of life and symptoms will be collected weekly during treatment and at follow-up visits. Researchers will monitor participants for safety and treatment effects during these visits, with the total study duration spanning several months.
CONDITIONS
Brief Title
Chemoablation for Low-Grade Bladder Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older who provide informed consent
- Diagnosis of recurrent or primary Ta low-grade bladder cancer confirmed by biopsy within 8 weeks before screening
- Largest tumor lesion diameter is 15 mm or less
- Five or fewer bladder tumor lesions present
- Cystoscopy with bladder diagram and photo documentation of tumors
- Recurrence of non-muscle invasive bladder cancer (low or intermediate risk)
- Requires treatment with transurethral resection of bladder tumors (TURBT)
- Negative voiding cytology for high-grade disease within 8 weeks before screening
- No lymph node or distant metastasis
- Use of effective contraception during study and for 6 months after treatment for males and females
- Negative pregnancy test within 2 weeks prior to enrollment for females of childbearing potential
- Willing and able to provide informed consent
You will not qualify if you...
- Tumors suspected to be high-grade by clinicians
- Positive high-grade cytology according to Paris criteria
- Tumor diameter greater than 15 mm
- More than five bladder tumor lesions
- Any previous intravesical therapy within 1 year
- Previous high-grade non-muscle invasive bladder cancer within last 3 years
- Past or current muscle invasive or metastatic bladder cancer
- History of upper tract urothelial carcinoma
- Clinically significant urethral stricture preventing catheter use
- History of neurogenic bladder or active urinary retention
- Active urinary tract infection not resolved before treatment
- Refusal to participate in the study
- Known positive HIV test
- Pregnant or breastfeeding females
- Females of childbearing potential not using adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants receive six weekly intravesical instillations of gemcitabine to treat low-grade bladder cancer.
Weekly visits for 6 weeks
Follow-up
Duration - 3 months
Participants are monitored for treatment response and safety with visits at 1 and 3 months post-treatment.
2 visits (in-person) at 1 and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Department of Urology, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
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Research Team
E
Ekaterina Laukhtina Dr., Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder.
Truls Gårdmark, Malcolm Carringer, Eva Beckman...
https://pubmed.ncbi.nlm.nih.gov/16140071Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder.
Massimo Maffezzini, Fabio Campodonico, Giorgio Canepa...
https://pubmed.ncbi.nlm.nih.gov/17027141Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability.
Fabio Campodonico, Giorgio Canepa, Giacomo Capponi...
https://pubmed.ncbi.nlm.nih.gov/16080464Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions.
Vincenzo Serretta, Antonino Galuffo, Carlo Pavone...
https://pubmed.ncbi.nlm.nih.gov/15667865Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC).
Paolo Gontero, Giovanni Casetta, Gloria Maso...
https://pubmed.ncbi.nlm.nih.gov/15306105