Bladder CancerNCT05084586
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation
A study testing Intravesical Solution in people with Bladder Cancer and Epirubicin Adverse Reaction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer, Epirubicin Adverse Reaction, Superficial Bladder Cancer
- What is being tested?
- Intravesical Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 5 Nov 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low and intermediate risk NMIBC
Who cannot join
- High risk NMIBC
- Patients who received intravesical BCG
- Postoperative gross hematuria
- Bladder perforation
- Pregnancy
- Urinary tract infection
- Epirubicin allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Training and Research Hospital
Ankara, Altindag, 06230
Ali Kaan Yildiz, +90 554 773 16 96, alikaanyildiz@gmail.com
About this study
Official title: Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer
In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.
Read the detailed description
Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer).
Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups.
Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.
- Being tested
- Intravesical Solution
- Keywords
- Non-Muscle Invasive Bladder Cancer, Epirubicin, Intravesical Chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical SolutionDrug
Also called Continuous Epirubicin Instillation During the Early Postoperative Period
After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 150 ml saline was continuously instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
Intravesical SolutionDrug
Also called Single-Dose Epirubicin Instillation During the Early Postoperative Period
After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 50 ml saline was instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Intravesical Infusion of Epirubicin | Active comparator | Patients who received continuous epirubicin infusion into the bladder in the early postoperative period. Receives: Drug: Intravesical Solution |
| Single-Dose Instillation of Epirubicin | Sham comparator | Patients who received single-dose epirubicin into the bladder in the early postoperative period. Receives: Drug: Intravesical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tumor Recurrence and Progression
Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Oct 2019
- Primary completion5 Oct 2023 (estimated)
- Study completion5 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084586
- Sponsor's protocol ID
- BC2021EPI
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Engeler DS, Wyler S, Neyer M, Hobi C, Muller J, Schmid HP. Feasibility of early intravesical instillation chemotherapy after transurethral resection of the bladder: a prospective evaluation in a consecutive series of 210 cases. Scand J Urol Nephrol. 2008;42(6):522-7. doi: 10.1080/00365590802133099.
PubMed 18609290Maekawa S, Suzuki H, Ohkubo K, Aoki Y, Okada T, Maeda H, Ogura K, Arai Y. [Continuous intravesical instillation of epirubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study]. Hinyokika Kiyo. 2000 May;46(5):301-6. Japanese.
PubMed 10876750Wu ZB, Lin GB, Chen BJ, Wu ZM, Rong RM. [Efficacy and safety of different dosages of intravesical epirubicin instillation for prevention of primary superficial bladder carcinoma from recurrence]. Zhonghua Zhong Liu Za Zhi. 2005 Aug;27(8):507-9. Chinese.
PubMed 16188156
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer
- ClinicalTrials.gov ID
- NCT05084586
- Acronym / sponsor ID
- BC2021EPI
- Keywords
- Non-Muscle Invasive Bladder Cancer, Epirubicin, Intravesical Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Oct 2023 (estimated)
- Study completion
- 5 Nov 2023 (estimated)
- First posted
- 20 Oct 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.
In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.
Detailed description
Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer).
Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups.
Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Intravesical Infusion of Epirubicin | Active comparator | Drug: Intravesical SolutionPatients who received continuous epirubicin infusion into the bladder in the early postoperative period. |
| Single-Dose Instillation of Epirubicin | Sham comparator | Drug: Intravesical SolutionPatients who received single-dose epirubicin into the bladder in the early postoperative period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low and intermediate risk NMIBC
Key exclusion criteria (7 listed)
- High risk NMIBC
- Patients who received intravesical BCG
- Postoperative gross hematuria
- Bladder perforation
- Pregnancy
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 |
|---|---|---|
| Intravesical SolutionAlso: Continuous Epirubicin Instillation During the Early Postoperative PeriodAfter the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 150 ml saline was continuously instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution. | Drug | Continuous Intravesical Infusion of Epirubicin |
| Intravesical SolutionAlso: Single-Dose Epirubicin Instillation During the Early Postoperative PeriodAfter the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 50 ml saline was instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution. | Drug | Single-Dose Instillation of Epirubicin |
Primary outcome
Rate of Tumor Recurrence and Progression
Time frame: 1 year
Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 18609290Engeler DS, Wyler S, Neyer M, Hobi C, Muller J, Schmid HP. Feasibility of early intravesical instillation chemotherapy after transurethral resection of the bladder: a prospective evaluation in a consecutive series of 210 cases. Scand J Urol Nephrol. 2008;42(6):522-7. doi: 10.1080/00365590802133099.
- Background: PubMed 10876750Maekawa S, Suzuki H, Ohkubo K, Aoki Y, Okada T, Maeda H, Ogura K, Arai Y. [Continuous intravesical instillation of epirubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study]. Hinyokika Kiyo. 2000 May;46(5):301-6. Japanese.
- Background: PubMed 16188156Wu ZB, Lin GB, Chen BJ, Wu ZM, Rong RM. [Efficacy and safety of different dosages of intravesical epirubicin instillation for prevention of primary superficial bladder carcinoma from recurrence]. Zhonghua Zhong Liu Za Zhi. 2005 Aug;27(8):507-9. Chinese.
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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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravesical Solution in people with Bladder Cancer and Epirubicin Adverse Reaction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ali Kaan Yildiz (+90 554 773 16 96, alikaanyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Tumor Recurrence and Progression (time frame: 1 year). 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 NCT05084586, which also lists 3 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 28 Mar 2023.