Bladder CancerPhase 3GENSANCT04947059
Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
A Phase 3 study testing Gemcitabine Hydrochloride combined with continuous saline irrigation and Epirubicin Hydrochloride combined with continuous saline irrigation in people with Bladder Cancer, run by University of Thessaly at 1 site in Greece.
Trial summary
The natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Gemcitabine Hydrochloride combined with continuous saline irrigation and Epirubicin Hydrochloride combined with continuous saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 14 Dec 2021to Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary urinary bladder tumor
- Secondary urinary bladder tumor (recurrence)
- Bipolar or monopolar resection
- Creat <2.2mg/dl
- 35% <Hct <52%
- White bloode cells count WBC ≥3000 / μL
Show all 11Show fewer
- 75000 <PLT <500000 / μL
- Urine culture: negative / sterile
- Alkaline phosphatase, total bilirubin, SGOT, SGPT: values as high as 2 times above the upper normal limit
- Good clinical condition (according to Eastern Cooperative Oncology Group PS ≤ 1)
- CT Urography without findings suggesting an upper urinary tract tumor in the last 3 months before the transurethral resection of the bladder tumor
Who cannot join
- More than 2 low grade / high differentiation (low grade / LG) histologically confirmed bladder tumors in the last 18 months before the transurethral resection of the bladder tumor
- High grade / low differentiation (HG) histologically confirmed bladder tumor in the last 9 months before the transurethral resection of the bladder tumor
- Those who undergo a transurethral resection of a bladder tumor according to the Guidelines of the European Association of Urology for non-muscle-invasive bladder cancer: incomplete resection of tumor, absence of muscle fibers in the sample with the exception of: Ta / LG-G1, primary Cis and finally, pT1 tumors
- Intravesical instillation of chemotherapeutic agent or BCG in the last 6 months before the transurethral resection of the bladder tumor
- History of non-urothelial bladder cancer
- Stage of disease pT2 (muscle-invasive bladder cancer)
Show all 10Show fewer
- Presence of a tumor in the urethra
- Upper urinary tract malignancy (present or anamnestically)
- History of pelvic radiotherapy
- Histrory of another malignancy in the last 5 years before the transurethral resection of the bladder tumor
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Urology Department, University of Thessaly, University Hospital of Larissa
Larissa, Larissa/Thessaly, 41110
Vasileios Tzortzis, Professor, 00302413502811, urologydpt.uth@gmail.com
Lampros Mitrakas, Consultant, 00302413501325, lamprosmit@gmail.com
About this study
Official title: A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
The natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.
Read the detailed description
Bladder cancer (BLCa) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. At diagnosis about 75% of the patients suffer from non-muscle-invasive BLCa. The natural history of this disease is characterised by recurrence and progression. In order to reduce the possibilities for recurrence, and therefore progression, an immediate single intravesical instillation (ISIVI) of a chemotherapeutic agent has been shown to act by destroying circulating tumour cells after transurethral resection of urinary bladder tumors (TURB), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours. Several agents, among them gemcitabine and epirubicin, have been used for the ISIVI so far. Moreover, four large meta-analyses comprising 1,476 to 3,103 patients have consistently shown that after TURB, ISIVI significantly reduces the recurrence rate compared to TURB alone. Furthermore, two meta-analyses suggest efficacy of continuous saline irrigation (CSI) in the prevention of early recurrences. The prevention of tumour cell implantation should be initiated within the first few hours after TURB. After that, tumour cells are firmly implanted and are covered by the extracellular matrix. In all ISIVI studies, the instillation was administered within 24 hours. Until today, no randomised comparisons of individual drugs, combined or not with CSI, have been conducted.
After the initial TURB, the patients will be treated with CSI for 24 hours. Then, they will be randomised, either to gemcitabine or epirubicin, and within 6 hours after the TURB they will receive an ISIVI with gemcitabine or epirubicin, as follows:
- GROUP A: Gemcitabine hydrochloride 2gr in 100ml 0.9% NaCl for 45-60 minutes
- GROUP B: Epirubicin hydrochloride 50mg in 50ml 0.9% NaCl for 45-60 minutes
During the ISIVI the CSI will be stopped.
The ISIVI will not be applied in the following cases:
- Active bleeding, which does not allow to interrupt the CSI
- Postoperative fever > 38°C
- Deep resection of the tumor, which could be associated with bladder perforation and therefore potential extravasation of the administered drug
- Known allergy to gemcitabine or epirubicin
The postoperative follow-up for patients with disease stage pTis, Ta, T1 low grade (LG) / high grade (HG), will be done according to the Guidelines of the European Association of Urology (EAU) for non-muscle-invasive bladder cancer, as follows:
- 1st and 2nd year: Cystoscopy \& cytological examination of urine every 3 months, CT Urography every 12 months for HG patients
- 3rd year: Cystoscopy \& cytological examination of urine every 6 months, CT Urography every 12 months for HG patients
- Conditions
- Bladder Cancer
- Being tested
- Gemcitabine Hydrochloride combined with continuous saline irrigation, Epirubicin Hydrochloride combined with continuous saline irrigation
- Keywords
- Postoperative intravesical instillation, Gemcitabine, Epirubicin
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine Hydrochloride combined with continuous saline irrigationDrug
Also called GROUP A
Immediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor
Epirubicin Hydrochloride combined with continuous saline irrigationDrug
Also called GROUP B
Immediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with gemcitabine hydrochloride 2gr in 100ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours Receives: Drug: Gemcitabine Hydrochloride combined with continuous saline irrigation |
| Epirubicin | Active comparator | Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with epirubicine hydrochloride 50mg in 50ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours Receives: Drug: Epirubicin Hydrochloride combined with continuous saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder cancer recurrence
Histologically proven bladder cancer recurrence
Measured: At 3 months after the transurethral resection of a bladder tumor
Bladder cancer progression
Histologically proven bladder cancer progression
Measured: At 3 months after the transurethral resection of a bladder tumor
Bladder cancer recurrence
Histologically proven bladder cancer recurrence
Measured: At 12 months after the transurethral resection of a bladder tumor
Bladder cancer progression
Histologically proven bladder cancer progression
Measured: At 12 months after the transurethral resection of a bladder tumor
Secondary outcomes (2)
Bladder cancer recurrence
Histologically proven bladder cancer recurrence
Measured: At 24 months after the transurethral resection of a bladder tumor
Bladder cancer progression
Histologically proven bladder cancer progression
Measured: At 24 months after the transurethral resection of a bladder tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start14 Dec 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bladder cancer patients, who are treated with a transurethral resection of the bladder tumor, receive postoperatively an immediate single intravesical instillation with either gemcitabine hydrochloride or epirubicine hydrochloride
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Tzortzis, University of Thessaly
- Investigators
- Vasileios Tzortzis, Professor, Principal investigator, Urology Department, University of Thessaly, University Hospital of Larissa, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947059
- Sponsor's protocol ID
- 11006/28.04.2021
- Acronym
- GENSA
- Status last verified
- Jan 2022
- First submitted
- 17 Jun 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
- ClinicalTrials.gov ID
- NCT04947059
- Acronym / sponsor ID
- GENSA / 11006/28.04.2021
- Conditions
- Bladder Cancer
- Keywords
- Postoperative intravesical instillation, Gemcitabine, Epirubicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Jul 2021 (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 natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.
Detailed description
Bladder cancer (BLCa) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. At diagnosis about 75% of the patients suffer from non-muscle-invasive BLCa. The natural history of this disease is characterised by recurrence and progression. In order to reduce the possibilities for recurrence, and therefore progression, an immediate single intravesical instillation (ISIVI) of a chemotherapeutic agent has been shown to act by destroying circulating tumour cells after transurethral resection of urinary bladder tumors (TURB), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours. Several agents, among them gemcitabine and epirubicin, have been used for the ISIVI so far. Moreover, four large meta-analyses comprising 1,476 to 3,103 patients have consistently shown that after TURB, ISIVI significantly reduces the recurrence rate compared to TURB alone. Furthermore, two meta-analyses suggest efficacy of continuous saline irrigation (CSI) in the prevention of early recurrences. The prevention of tumour cell implantation should be initiated within the first few hours after TURB. After that, tumour cells are firmly implanted and are covered by the extracellular matrix. In all ISIVI studies, the instillation was administered within 24 hours. Until today, no randomised comparisons of individual drugs, combined or not with CSI, have been conducted.
After the initial TURB, the patients will be treated with CSI for 24 hours. Then, they will be randomised, either to gemcitabine or epirubicin, and within 6 hours after the TURB they will receive an ISIVI with gemcitabine or epirubicin, as follows:
- GROUP A: Gemcitabine hydrochloride 2gr in 100ml 0.9% NaCl for 45-60 minutes
- GROUP B: Epirubicin hydrochloride 50mg in 50ml 0.9% NaCl for 45-60 minutes
During the ISIVI the CSI will be stopped.
The ISIVI will not be applied in the following cases:
- Active bleeding, which does not allow to interrupt the CSI
- Postoperative fever > 38°C
- Deep resection of the tumor, which could be associated with bladder perforation and therefore potential extravasation of the administered drug
- Known allergy to gemcitabine or epirubicin
The postoperative follow-up for patients with disease stage pTis, Ta, T1 low grade (LG) / high grade (HG), will be done according to the Guidelines of the European Association of Urology (EAU) for non-muscle-invasive bladder cancer, as follows:
- 1st and 2nd year: Cystoscopy \& cytological examination of urine every 3 months, CT Urography every 12 months for HG patients
- 3rd year: Cystoscopy \& cytological examination of urine every 6 months, CT Urography every 12 months for HG patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Bladder cancer patients, who are treated with a transurethral resection of the bladder tumor, receive postoperatively an immediate single intravesical instillation with either gemcitabine hydrochloride or epirubicine hydrochloride
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: Gemcitabine Hydrochloride combined with continuous saline irrigationBladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with gemcitabine hydrochloride 2gr in 100ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours |
| Epirubicin | Active comparator | Drug: Epirubicin Hydrochloride combined with continuous saline irrigationBladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with epirubicine hydrochloride 50mg in 50ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Primary urinary bladder tumor
- Secondary urinary bladder tumor (recurrence)
- Bipolar or monopolar resection
- Creat <2.2mg/dl
- 35% <Hct <52%
Key exclusion criteria (10 listed)
- More than 2 low grade / high differentiation (low grade / LG) histologically confirmed bladder tumors in the last 18 months before the transurethral resection of the bladder tumor
- High grade / low differentiation (HG) histologically confirmed bladder tumor in the last 9 months before the transurethral resection of the bladder tumor
- Those who undergo a transurethral resection of a bladder tumor according to the Guidelines of the European Association of Urology for non-muscle-invasive bladder cancer: incomplete resection of tumor, absence of muscle fibers in the sample with the exception of: Ta / LG-G1, primary Cis and finally, pT1 tumors
- Intravesical instillation of chemotherapeutic agent or BCG in the last 6 months before the transurethral resection of the bladder tumor
- History of non-urothelial bladder cancer
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 |
|---|---|---|
| Gemcitabine Hydrochloride combined with continuous saline irrigationAlso: GROUP AImmediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor | Drug | Gemcitabine |
| Epirubicin Hydrochloride combined with continuous saline irrigationAlso: GROUP BImmediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor | Drug | Epirubicin |
Primary outcome
Bladder cancer recurrence
Time frame: At 3 months after the transurethral resection of a bladder tumor
Histologically proven bladder cancer recurrence
Bladder cancer progression
Time frame: At 3 months after the transurethral resection of a bladder tumor
Histologically proven bladder cancer progression
Bladder cancer recurrence
Time frame: At 12 months after the transurethral resection of a bladder tumor
Histologically proven bladder cancer recurrence
Bladder cancer progression
Time frame: At 12 months after the transurethral resection of a bladder tumor
Histologically proven bladder cancer progression
2 secondary outcomes
Bladder cancer recurrence
Time frame: At 24 months after the transurethral resection of a bladder tumor
Bladder cancer progression
Time frame: At 24 months after the transurethral resection of a bladder tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Vasileios Tzortzis, Professor principal investigator
Urology Department, University of Thessaly, University Hospital of Larissa, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine Hydrochloride combined with continuous saline irrigation and Epirubicin Hydrochloride combined with continuous saline irrigation in people with Bladder Cancer, run by University of Thessaly at 1 site in Greece.
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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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 Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Tzortzis, Professor (00302413502811, urologydpt.uth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder cancer recurrence (time frame: At 3 months after the transurethral resection of a bladder tumor). The study lists 4 primary outcomes in all. 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 26 Jan 2022.