Bladder (Urothelial, Transitional Cell) CancerPhase 2COBRANCT07019220
Chemoablation for Low-Grade Bladder Cancer
A Phase 2 study testing Gemcitabine in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Ekaterina Laukhtina at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustria
- Study dates
- 27 Dec 2023to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ekaterina Laukhtina Dr., Medical Doctor contact
Austria1 site, 1 recruiting
- Recruiting
Department of Urology, Medical University of Vienna
Vienna, 1090
Ekaterina Laukhtina Dr., Medical Doctor, +43 (0)1 40400-26315, ekaterina.laukhtina@meduniwien.ac.at
About this study
Official title: COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study
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.
Read the 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.
- Being tested
- Gemcitabine
- Keywords
- Non-Muscle Invasive Bladder Cancer, Intravesical Therapy, Non-Surgical Treatment
- Medical subject headings
- Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Intravesical installation
| Study group | Role | What they receive |
|---|---|---|
| Patients with low-grade NMIBC | Experimental | Not described Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complete response (cCR)
cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation
Measured: From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).
Secondary outcomes (3)
Pathological complete response (pCR)
pCR defined as negative urine cytology, absence of macroscopic tumor at cystoscopic evaluation and confirmed by negative biopsy/TURB
Measured: From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).
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.
Measured: Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).
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.
Measured: Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start27 Dec 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ekaterina Laukhtina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ekaterina Laukhtina, Medical University of Vienna
- Investigators
- Shahrokh F. Shariat Prof. Dr., Professor, Principal investigator, Department of Urology, Medical University of Viernna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019220
- Sponsor's protocol ID
- COBRA
- Acronym
- COBRA
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study includes sensitive patient information related to medical history, treatment responses, and clinical outcomes. To protect patient confidentiality and comply with ethical guidelines and institutional policies, individual participant data will not be shared publicly
Publications
Brausi MA, Gontero P, Altieri V, Colombo R, Conti I, Bono AV. Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study. Urol Int. 2011;87(4):470-4. doi: 10.1159/000331727. Epub 2011 Nov 11.
PubMed 22086229Gardmark T, Carringer M, Beckman E, Malmstrom PU; Members of the Intravesical Gemcitabine Study Group. 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. Urology. 2005 Sep;66(3):527-30. doi: 10.1016/j.urology.2005.03.084.
PubMed 16140071Maffezzini M, Campodonico F, Canepa G, Capponi G, Fontana V. Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder. Eur Urol. 2007 Apr;51(4):956-61. doi: 10.1016/j.eururo.2006.08.038. Epub 2006 Sep 20.
PubMed 17027141Campodonico F, Canepa G, Capponi G, Bozzo L, Maffezzini M. Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability. Anticancer Res. 2005 May-Jun;25(3c):2381-4.
PubMed 16080464Serretta V, Galuffo A, Pavone C, Allegro R, Pavone-MacAluso M. Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions. Urology. 2005 Jan;65(1):65-9. doi: 10.1016/j.urology.2004.08.027.
PubMed 15667865Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol. 2004 Sep;46(3):339-43. doi: 10.1016/j.eururo.2004.05.001.
PubMed 15306105
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study
- ClinicalTrials.gov ID
- NCT07019220
- Acronym / sponsor ID
- COBRA / COBRA
- Keywords
- Non-Muscle Invasive Bladder Cancer, Intravesical Therapy, Non-Surgical Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Ekaterina LaukhtinaUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with low-grade NMIBC | Experimental | Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineIntravesical installation | Drug | Patients with low-grade NMIBC |
Primary outcome
Clinical complete response (cCR)
Time frame: 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
3 secondary outcomes
Pathological complete response (pCR)
Time frame: From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).
Patient-reported Outcomes based on EORTC QLQ-NMIBC24
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).
Patient-reported Outcomes based on EORTC QLQ-C30
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 22086229Brausi MA, Gontero P, Altieri V, Colombo R, Conti I, Bono AV. Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study. Urol Int. 2011;87(4):470-4. doi: 10.1159/000331727. Epub 2011 Nov 11.
- Background: PubMed 16140071Gardmark T, Carringer M, Beckman E, Malmstrom PU; Members of the Intravesical Gemcitabine Study Group. 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. Urology. 2005 Sep;66(3):527-30. doi: 10.1016/j.urology.2005.03.084.
- Background: PubMed 17027141Maffezzini M, Campodonico F, Canepa G, Capponi G, Fontana V. Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder. Eur Urol. 2007 Apr;51(4):956-61. doi: 10.1016/j.eururo.2006.08.038. Epub 2006 Sep 20.
- Background: PubMed 16080464Campodonico F, Canepa G, Capponi G, Bozzo L, Maffezzini M. Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability. Anticancer Res. 2005 May-Jun;25(3c):2381-4.
- Background: PubMed 15667865Serretta V, Galuffo A, Pavone C, Allegro R, Pavone-MacAluso M. Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions. Urology. 2005 Jan;65(1):65-9. doi: 10.1016/j.urology.2004.08.027.
- Background: PubMed 15306105Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol. 2004 Sep;46(3):339-43. doi: 10.1016/j.eururo.2004.05.001.
- Individual participant dataSharing planned: No. The data collected in this study includes sensitive patient information related to medical history, treatment responses, and clinical outcomes. To protect patient confidentiality and comply with ethical guidelines and institutional policies, individual participant data will not be shared publicly
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ekaterina Laukhtina Dr., Medical Doctor contact
Shahrokh F. Shariat Prof. Dr., Professor principal investigator
Department of Urology, Medical University of Viernna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Ekaterina Laukhtina at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Laukhtina Dr., Medical Doctor (+43 (0)1 40400-26315, ekaterina.laukhtina@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response (cCR) (time frame: From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019220, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.