Carcinoma of Urinary Bladder, SuperficialPhase 4NMIBCIVTNCT02214602
Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer
A Phase 4 study testing Epirubicin in people with Carcinoma of Urinary Bladder, Superficial, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Urinary Bladder, Superficial
- What is being tested?
- Epirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2014to May 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC).
- Complete transurethral resection of bladder tumor(TURBT).
- Normal cardiac, hematological, and renal functions.
- Patients with intermediate and high risk NMIBC confirmed by histopathology.
Who cannot join
- Inability to give informed consent.
- Patients with history of previous radiotherapy or systemic chemotherapy.
- Patients suffering from immuno-deficiency or other malignancies.
- Patients with history of hypersensitivity reaction to epirubicin.
- Examination under anesthesia (EUA) reveals palpable bladder mass.
- Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk).
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- Suspicion of perforation of the bladder during TURBT.
- Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis.
- Patients with proven low risk NMIBC on histopathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
Read the detailed description
Preoperative evaluation will be carried out in the form of routine laboratory investigations, abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI) abdomen and pelvis if necessary. Then, the patients will be subjected to complete TURBT.
The patients will be transferred to the recovery room, careful monitoring of the patients will be carried out for the 1st 30 min, and then after confirming the patient eligibility for enrollment in the study by exclusion of cases with hematuria and suspicious bladder perforation, patients will be enrolled randomly into one of the two groups. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio or by the method of closed envelopes.
The 1st group will not receive intravesical instillation of epirubicin -Placebo-(control group), and, the 2nd group will receive intravesical instillation of epirubicin 50 mg in 50 ml saline 0.9% (study group) with clamping of the urethral catheter for 1 hour after instillation and during this period the patients are monitored for local or systemic adverse events (acute abdomen, chills, fever, hot flushes, abdominal rigidity, hematuria after de-clamping of the catheter).
Evaluation:
Intraoperative and early postoperative parameters of interest will be recorded and compared between the two groups like EUA findings, tumor characteristics during cystoscopy as the tumor size, site, shape, number, suspicion of CIS, post instillation adverse events, cytology and biopsy results.
The patients will be discharged after removal of urethral catheter. They will be stratified into either intermediate or high risk histopathologically confirmed NMIBC, followed up at the outpatient clinic (OPC) and will receive adjuvant intravesical instillation of chemotherapy or immunotherapy according to the European Association of Urology (EAU) guidelines for each risk group. The patients will be evaluated by office cystoscopy and urine cytology at the OPC after 12 weeks, and thereafter every 3 months during the first 2 years and then every 3 to 6 months according to the risk category.
During the follow-up period, all histopathologically confirmed tumors will be classified as recurrences. Time to first recurrence will be the primary end point of the study, and the length of follow-up will be defined as the time from inclusion to the last cystoscopy control.
Methods of evaluation and follow-up:
All the patients will be evaluated on entry and at follow-up intervals. On study entry patients will be evaluated by urinalysis, urine culture, serum creatinine, fasting blood sugar level, complete blood count, chest X-ray, excretory urography (IVU) and or CT urography and bladder wash for cytology. CT with contrast will be performed annually in cases of high risk tumor category and when otherwise indicated. Complete TURBT of all visible tumors will be conducted in all patients and the stage and grade will be determined according to the 1987 staging classification and World Health Organization (WHO) grading system in 1973+ 2004 WHO grading system.
- Being tested
- Epirubicin
- Keywords
- non muscle invasive bladder cancer, intermediate and high risk, immediate single instillation, Intravesical chemotherapy, Disease prevention
- 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.
EpirubicinDrug
Also called Intravesical chemotherapy, Doxorubicin
Experimental: Study group(Epirubicin)
in the arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor
| Study group | Role | What they receive |
|---|---|---|
| Study group(Epirubicin) | Experimental | in this arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor Receives: Drug: Epirubicin |
| Control group | No intervention | in this arm -control group- : patients will not receive immediate intravesical instillation of of epirubicin after compete transurethral resection of bladder tumor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence, progression and/or death from cancer.
Measured: within the 1st year after complete Transurethral resection of bladder tumor
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: within 1st 24 hours following intravesical instillation of the used drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma of Urinary Bladder, SuperficialStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Bedeir A El-Dein, Professor, Study chair, Urology And Nephrology Center, Mansoura University, Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214602
- Sponsor's protocol ID
- AEl-Sawy172014
- Acronym
- NMIBCIVT
- Status last verified
- Mar 2018
- First submitted
- 10 Jul 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B. The value of immediate postoperative intravesical epirubicin instillation as an adjunct to standard adjuvant treatment in intermediate and high-risk non-muscle-invasive bladder cancer: A preliminary results of randomized controlled trial. Urol Oncol. 2019 Mar;37(3):179.e9-179.e18. doi: 10.1016/j.urolonc.2018.10.019. Epub 2018 Nov 14.
PubMed 30448030
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02214602
- Acronym / sponsor ID
- NMIBCIVT / AEl-Sawy172014
- Keywords
- non muscle invasive bladder cancer, intermediate and high risk, immediate single instillation, Intravesical chemotherapy, Disease prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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 aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
Detailed description
Preoperative evaluation will be carried out in the form of routine laboratory investigations, abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI) abdomen and pelvis if necessary. Then, the patients will be subjected to complete TURBT.
The patients will be transferred to the recovery room, careful monitoring of the patients will be carried out for the 1st 30 min, and then after confirming the patient eligibility for enrollment in the study by exclusion of cases with hematuria and suspicious bladder perforation, patients will be enrolled randomly into one of the two groups. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio or by the method of closed envelopes.
The 1st group will not receive intravesical instillation of epirubicin -Placebo-(control group), and, the 2nd group will receive intravesical instillation of epirubicin 50 mg in 50 ml saline 0.9% (study group) with clamping of the urethral catheter for 1 hour after instillation and during this period the patients are monitored for local or systemic adverse events (acute abdomen, chills, fever, hot flushes, abdominal rigidity, hematuria after de-clamping of the catheter).
Evaluation:
Intraoperative and early postoperative parameters of interest will be recorded and compared between the two groups like EUA findings, tumor characteristics during cystoscopy as the tumor size, site, shape, number, suspicion of CIS, post instillation adverse events, cytology and biopsy results.
The patients will be discharged after removal of urethral catheter. They will be stratified into either intermediate or high risk histopathologically confirmed NMIBC, followed up at the outpatient clinic (OPC) and will receive adjuvant intravesical instillation of chemotherapy or immunotherapy according to the European Association of Urology (EAU) guidelines for each risk group. The patients will be evaluated by office cystoscopy and urine cytology at the OPC after 12 weeks, and thereafter every 3 months during the first 2 years and then every 3 to 6 months according to the risk category.
During the follow-up period, all histopathologically confirmed tumors will be classified as recurrences. Time to first recurrence will be the primary end point of the study, and the length of follow-up will be defined as the time from inclusion to the last cystoscopy control.
Methods of evaluation and follow-up:
All the patients will be evaluated on entry and at follow-up intervals. On study entry patients will be evaluated by urinalysis, urine culture, serum creatinine, fasting blood sugar level, complete blood count, chest X-ray, excretory urography (IVU) and or CT urography and bladder wash for cytology. CT with contrast will be performed annually in cases of high risk tumor category and when otherwise indicated. Complete TURBT of all visible tumors will be conducted in all patients and the stage and grade will be determined according to the 1987 staging classification and World Health Organization (WHO) grading system in 1973+ 2004 WHO grading system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group(Epirubicin) | Experimental | Drug: Epirubicinin this arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor |
| Control group | No intervention | –in this arm -control group- : patients will not receive immediate intravesical instillation of of epirubicin after compete transurethral resection of bladder tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to give informed consent.
- Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC).
- Complete transurethral resection of bladder tumor(TURBT).
- Normal cardiac, hematological, and renal functions.
- Patients with intermediate and high risk NMIBC confirmed by histopathology.
Key exclusion criteria (9 listed)
- Inability to give informed consent.
- Patients with history of previous radiotherapy or systemic chemotherapy.
- Patients suffering from immuno-deficiency or other malignancies.
- Patients with history of hypersensitivity reaction to epirubicin.
- Examination under anesthesia (EUA) reveals palpable bladder mass.
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 |
|---|---|---|
| EpirubicinAlso: Intravesical chemotherapy, DoxorubicinExperimental: Study group(Epirubicin) in the arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor | Drug | Study group(Epirubicin) |
Primary outcome
Recurrence, progression and/or death from cancer.
Time frame: within the 1st year after complete Transurethral resection of bladder tumor
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: within 1st 24 hours following intravesical instillation of the used drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 30448030Elsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B. The value of immediate postoperative intravesical epirubicin instillation as an adjunct to standard adjuvant treatment in intermediate and high-risk non-muscle-invasive bladder cancer: A preliminary results of randomized controlled trial. Urol Oncol. 2019 Mar;37(3):179.e9-179.e18. doi: 10.1016/j.urolonc.2018.10.019. Epub 2018 Nov 14.
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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.
Bedeir A El-Dein, Professor study chair
Urology And Nephrology Center, Mansoura University, Mansoura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epirubicin in people with Carcinoma of Urinary Bladder, Superficial, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 Mar 2018. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence, progression and/or death from cancer. (time frame: within the 1st year after complete Transurethral resection of bladder tumor). 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 NCT02214602, which also lists 1 linked publication.
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 22 Mar 2018.