Non-Muscle-Invasive Bladder CancerPhase 2GEMDOC-MMCNCT07747740
Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
A Phase 2 study testing Gemcitabin, Docetaxel and Mitomicin C in people with Non-Muscle-Invasive Bladder Cancer and BCG-Unresponsive Bladder Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer, BCG-Unresponsive Bladder Cancer
- What is being tested?
- Gemcitabin, Docetaxel and Mitomicin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jul 2026to 30 Dec 2030
- 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
- Age ≥18 years.
- Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
- Complete transurethral resection of bladder tumor (TURBT) before study treatment.
- Intermediate- or high-risk NMIBC according to current clinical guidelines.
- Candidate for intravesical chemotherapy.
- ECOG performance status 0-2.
- Adequate hematologic, renal, and hepatic function.
- Written informed consent.
Who cannot join
- Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
- Upper urinary tract urothelial carcinoma requiring treatment.
- Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
- Active uncontrolled urinary tract infection.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional clinical trial.
- Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Moscow, 115522
Nshan Sedrakyan, MD
About this study
Official title: A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
Read the detailed description
High-grade BCG-unresponsive non-muscle-invasive bladder cancer remains a major therapeutic challenge. Radical cystectomy is considered the standard treatment; however, many patients are unwilling or medically unfit to undergo surgery. Sequential intravesical chemotherapy has emerged as a bladder-preserving treatment strategy with encouraging oncological outcomes.
This prospective, randomized, open-label, single-center phase II trial is designed to compare the efficacy and safety of two sequential intravesical chemotherapy regimens following complete TURBT.
Eligible patients with histologically confirmed BCG-unresponsive high-grade NMIBC will be randomized in a 1:1 ratio to receive either sequential intravesical gemcitabine followed by docetaxel or sequential intravesical gemcitabine followed by mitomycin C.
Both treatment regimens consist of a six-week induction course followed by monthly maintenance instillations for twelve months according to the study protocol. Clinical follow-up includes cystoscopy, urine cytology, pelvic ultrasonography, adverse event assessment according to CTCAE criteria, and quality-of-life evaluation using the EORTC QLQ-C30 and EORTC QLQ-NMIBC24 questionnaires.
The primary endpoint is 12-month event-free survival. Secondary endpoints include cystectomy-free survival, progression-free survival, safety, tolerability, and comparative efficacy of both treatment strategies.
A total of 228 participants will be enrolled. Statistical analyses will be performed according to the intention-to-treat principle using Kaplan-Meier survival analysis, log-rank testing, and Cox proportional hazards regression.
- Being tested
- Gemcitabin, Docetaxel, Mitomicin C
- Keywords
- Gemcitabine, Docetaxel, Mitomycin C, Intravesical Chemotherapy, BCG-Unresponsive NMIBC, Randomized Trial, Bladder Preservation, TURBT, Event-Free Survival
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabinDrug
Intravesical gemcitabine 1 g dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes before drainage.
DocetaxelDrug
Also called Taxotere
Intravesical docetaxel 37.5 mg dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 to 120 minutes following gemcitabine administration.
Mitomicin CDrug
Intravesical mitomycin C 40 mg dissolved in 40 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes following gemcitabine administration.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Gemcitabine + Docetaxel | Experimental | Participants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months. Receives: Drug: Gemcitabin; Drug: Docetaxel |
| Sequential Gemcitabine + Mitomycin C | Active comparator | Participants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months. Receives: Drug: Gemcitabin; Drug: Mitomicin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Event-Free Survival
Event-free survival is defined as the time from randomization to the first occurrence of histologically confirmed recurrence, disease progression to muscle-invasive bladder cancer, radical cystectomy, distant metastasis, or death from any cause.
Measured: 12 months after randomization
Secondary outcomes (5)
Progression-Free Survival
Time from randomization to progression to muscle-invasive or metastatic urothelial carcinoma.
Measured: Up to 12 months
Cystectomy-Free Survival
Time from randomization to radical cystectomy for bladder cancer.
Measured: Up to 12 months
Treatment-Related Adverse Events
Incidence and severity of adverse events graded according to CTCAE.
Measured: Throughout study treatment and follow-up
Health-Related Quality of Life (EORTC QLQ-C30)
Change from baseline in EORTC QLQ-C30 scores.
Measured: Baseline through 12 months
Health-Related Quality of Life (EORTC QLQ-NMIBC24)
Change from baseline in EORTC QLQ-NMIBC24 scores.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start9 Jul 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-Invasive Bladder 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C following complete TURBT. Randomization will be stratified according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vsevolod Matveev, MD, PhD, Principal investigator, N.N. Blokhin National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747740
- Sponsor's protocol ID
- NMIBC-GEMDOC-001
- Acronym
- GEMDOC-MMC
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07747740
- Acronym / sponsor ID
- GEMDOC-MMC / NMIBC-GEMDOC-001
- Keywords
- Gemcitabine, Docetaxel, Mitomycin C, Intravesical Chemotherapy, BCG-Unresponsive NMIBC, Randomized Trial, Bladder Preservation, TURBT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 5 Aug 2026 (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.
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
Detailed description
High-grade BCG-unresponsive non-muscle-invasive bladder cancer remains a major therapeutic challenge. Radical cystectomy is considered the standard treatment; however, many patients are unwilling or medically unfit to undergo surgery. Sequential intravesical chemotherapy has emerged as a bladder-preserving treatment strategy with encouraging oncological outcomes.
This prospective, randomized, open-label, single-center phase II trial is designed to compare the efficacy and safety of two sequential intravesical chemotherapy regimens following complete TURBT.
Eligible patients with histologically confirmed BCG-unresponsive high-grade NMIBC will be randomized in a 1:1 ratio to receive either sequential intravesical gemcitabine followed by docetaxel or sequential intravesical gemcitabine followed by mitomycin C.
Both treatment regimens consist of a six-week induction course followed by monthly maintenance instillations for twelve months according to the study protocol. Clinical follow-up includes cystoscopy, urine cytology, pelvic ultrasonography, adverse event assessment according to CTCAE criteria, and quality-of-life evaluation using the EORTC QLQ-C30 and EORTC QLQ-NMIBC24 questionnaires.
The primary endpoint is 12-month event-free survival. Secondary endpoints include cystectomy-free survival, progression-free survival, safety, tolerability, and comparative efficacy of both treatment strategies.
A total of 228 participants will be enrolled. Statistical analyses will be performed according to the intention-to-treat principle using Kaplan-Meier survival analysis, log-rank testing, and Cox proportional hazards regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C following complete TURBT. Randomization will be stratified according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Sequential Gemcitabine + Docetaxel | Experimental | Drug: Gemcitabin, Drug: DocetaxelParticipants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months. |
| Sequential Gemcitabine + Mitomycin C | Active comparator | Drug: Gemcitabin, Drug: Mitomicin CParticipants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
- Complete transurethral resection of bladder tumor (TURBT) before study treatment.
- Intermediate- or high-risk NMIBC according to current clinical guidelines.
- Candidate for intravesical chemotherapy.
Key exclusion criteria (7 listed)
- Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
- Upper urinary tract urothelial carcinoma requiring treatment.
- Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
- Active uncontrolled urinary tract infection.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| GemcitabinIntravesical gemcitabine 1 g dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes before drainage. | Drug | Sequential Gemcitabine + Docetaxel, Sequential Gemcitabine + Mitomycin C |
| DocetaxelAlso: TaxotereIntravesical docetaxel 37.5 mg dissolved in 50 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 to 120 minutes following gemcitabine administration. | Drug | Sequential Gemcitabine + Docetaxel |
| Mitomicin CIntravesical mitomycin C 40 mg dissolved in 40 mL of 0.9% sodium chloride. The solution is retained in the bladder for 90 minutes following gemcitabine administration. | Drug | Sequential Gemcitabine + Mitomycin C |
Primary outcome
12-Month Event-Free Survival
Time frame: 12 months after randomization
Event-free survival is defined as the time from randomization to the first occurrence of histologically confirmed recurrence, disease progression to muscle-invasive bladder cancer, radical cystectomy, distant metastasis, or death from any cause.
5 secondary outcomes
Progression-Free Survival
Time frame: Up to 12 months
Cystectomy-Free Survival
Time frame: Up to 12 months
Treatment-Related Adverse Events
Time frame: Throughout study treatment and follow-up
Health-Related Quality of Life (EORTC QLQ-C30)
Time frame: Baseline through 12 months
Health-Related Quality of Life (EORTC QLQ-NMIBC24)
Time frame: Baseline through 12 months
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 5 Aug 2026.
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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.
Vsevolod Matveev, MD, PhD principal investigator
N.N. Blokhin National Medical Research Center of Oncology
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 Gemcitabin, Docetaxel and Mitomicin C in people with Non-Muscle-Invasive Bladder Cancer and BCG-Unresponsive Bladder Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 8 inclusion and 7 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 5 Aug 2026. 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 Russia. 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 Nshan Sedrakyan, MD (+79165663100, nick977773@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Event-Free Survival (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.