Transitional Cell Bladder CancerNCT07043790
Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma
A study testing Radical cystectomy with pelvic lymphadenectomy and Trimodal therapy in people with Transitional Cell Bladder Cancer and Cystectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
the aim of this study is to compare the oncological outcome of trimodal therapy with bladder preservation using maximal resection with chemoradiation versus the standard radical cystectomy for muscle invasive transitional cell carcinoma of urinary bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Bladder Cancer, Cystectomy, Radiation
- What is being tested?
- Radical cystectomy with pelvic lymphadenectomy and Trimodal therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 25 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of any gender, aged 18 years or older.
- Histologically confirmed urothelial (transitional cell) carcinoma (TCC) of the urinary bladder, clinical stage T2N0M0, diagnosed through:
- Imaging (CT or MRI).
- Cystoscopy.
- Biopsy and histopathological examination of the tumor.
Who cannot join
- Evidence of significant nodal involvement on imaging.
- Presence of carcinoma in situ (CIS).
- Hydronephrosis attributed to the bladder tumor.
- Non-TCC histology of bladder cancer.
- TCC with atypical histological variants including:
- Micropapillary,
Show all 14Show fewer
- Plasmacytoid,
- Anaplastic, or
- Sarcomatoid variants.
- High-grade non-muscle invasive bladder cancer (NMIBC).
- Patients unfit for surgery.
- Patients unfit for chemotherapy or radiotherapy.
- Refusal to undergo randomization.
- Prior chemotherapy or radiotherapy for bladder cancer.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study is to compare the oncological outcome of trimodal therapy with bladder preservation using maximal resection with chemoradiation versus the standard radical cystectomy for muscle invasive transitional cell carcinoma of urinary bladder.
Read the detailed description
Bladder cancer is the 9th most common cancer in the world, accounting for approximately 5-8% of all male cancers which makes it the 4th most common cancer in men and accounts for approximately 2% of female cancers making it the 8th most common cancer among women .
Bladder cancer is the 2nd most common urogenital cancer; thus, it is considered a very frequent disease to deal with in urological practice .
The urinary bladder is lined internally with transitional epithelial cells (urothelium), followed by lamina propria which is formed of connective tissue supporting the overlying urothelium, then muscularis propria (detrusor muscle) followed by an outer layer called serosa .
Bladder cancer is usually presented by gross or microscopic hematuria (85-90%), it may be associated with irritative symptoms, especially in the presence of carcinoma in situ.
In advanced disease, the patient may complain of bone pain, loin pain, pain radiating to the buttocks and thighs, or even renal impairment due to obstruction of both lower ureters.
Diagnosis and staging of bladder cancer are multimodal approaches done through a combination of clinical, radiological, and histopathological means.
Magnetic resonant imaging MRI lacks ionizing radiation, so it is considered a safe way to investigate a patient with cancer bladder before, during, or following up the treatment to determine its response .
Diagnostic cystoscopy is the only definitive diagnostic tool through histopathological examination of the resected tissues. Proper sampling should include the underlying muscularis propria. Transurethral resection of bladder tumor (TURBT) can miss proper muscle layer sampling in 25% of invasive cancer leading to under-staging. TURBT depends on the surgeon's experience, so the tumor-free rate varies widely .
Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans. Treatment methods aim at preserving the quality of life and reduce stage progression. The usual conservative approach in MIBC is a trimodal treatment (TMT). It consists of a transurethral resection of the bladder tumor (TURBT) as complete as possible, followed by concomitant radiotherapy (RT) and chemotherapy (CT). Response to radiotherapy and chemotherapy is then assessed by cystoscopy and biopsies. Planned surgery is proposed to non-responders and additional chemotherapy and RT with careful regular endoscopic examination is performed in responders .
Except for the incomplete selective bladder preservation against radical excision (SPARE) trial, there is no large and meaningful randomized trial comparing radical cystectomy and TMT .
- Conditions
- Transitional Cell Bladder Cancer, Cystectomy, Radiation
- Being tested
- Radical cystectomy with pelvic lymphadenectomy, Trimodal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical cystectomy with pelvic lymphadenectomyOther
Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina).
Standard pelvic lymph node dissection was performed to all patients in this group.
Trimodal therapyRadiation
Group B : trimodal therapy group
the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges.
This was followed by radio-sensitizing chemotherapy and radiotherapy..
Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2).
Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY
| Study group | Role | What they receive |
|---|---|---|
| Radical Cystectomy group | Active comparator | Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina).
Standard pelvic lymph node dissection was performed to all patients in this group. Receives: Other: Radical cystectomy with pelvic lymphadenectomy |
| Trimodal therapy group | Active comparator | Group B : trimodal therapy group
the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges.
This was followed by radio-sensitizing chemotherapy and radiotherapy..
Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2).
Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY Receives: Radiation: Trimodal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Disease free survival
Measured: 3 years
Cancer specific survival
Measured: 3 years
Secondary outcomes (1)
Complications of intervention
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Apr 2021
- Primary completion3 Apr 2025
- Study completion25 Apr 2025
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 Transitional Cell Bladder CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled clinical trial comparing radical cystectomy and trimodal therapy, included adult patients with cT2N0M0 muscle invasive localized urinary bladder TCC presented to our urology clinic.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Himdan Abdelhameed, Ain Shams University
- Investigators
- Ahmed Lotfy Ghazy, Lecturer of Urology, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043790
- Sponsor's protocol ID
- MD 183/2022
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.
PubMed 30763236Imai S, Yamada T, Kasashi K, Niinuma Y, Kobayashi M, Iseki K. Construction of a risk prediction model of vancomycin-associated nephrotoxicity to be used at the time of initial therapeutic drug monitoring: A data mining analysis using a decision tree model. J Eval Clin Pract. 2019 Feb;25(1):163-170. doi: 10.1111/jep.13039. Epub 2018 Oct 2.
PubMed 30280456Ritch CR, Balise R, Prakash NS, Alonzo D, Almengo K, Alameddine M, Venkatramani V, Punnen S, Parekh DJ, Gonzalgo ML. Propensity matched comparative analysis of survival following chemoradiation or radical cystectomy for muscle-invasive bladder cancer. BJU Int. 2018 May;121(5):745-751. doi: 10.1111/bju.14109. Epub 2018 Jan 22.
PubMed 29281848
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07043790
- Acronym / sponsor ID
- MD 183/2022
- Conditions
- Transitional Cell Bladder Cancer, Cystectomy, Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 29 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 aim of this study is to compare the oncological outcome of trimodal therapy with bladder preservation using maximal resection with chemoradiation versus the standard radical cystectomy for muscle invasive transitional cell carcinoma of urinary bladder.
Detailed description
Bladder cancer is the 9th most common cancer in the world, accounting for approximately 5-8% of all male cancers which makes it the 4th most common cancer in men and accounts for approximately 2% of female cancers making it the 8th most common cancer among women .
Bladder cancer is the 2nd most common urogenital cancer; thus, it is considered a very frequent disease to deal with in urological practice .
The urinary bladder is lined internally with transitional epithelial cells (urothelium), followed by lamina propria which is formed of connective tissue supporting the overlying urothelium, then muscularis propria (detrusor muscle) followed by an outer layer called serosa .
Bladder cancer is usually presented by gross or microscopic hematuria (85-90%), it may be associated with irritative symptoms, especially in the presence of carcinoma in situ.
In advanced disease, the patient may complain of bone pain, loin pain, pain radiating to the buttocks and thighs, or even renal impairment due to obstruction of both lower ureters.
Diagnosis and staging of bladder cancer are multimodal approaches done through a combination of clinical, radiological, and histopathological means.
Magnetic resonant imaging MRI lacks ionizing radiation, so it is considered a safe way to investigate a patient with cancer bladder before, during, or following up the treatment to determine its response .
Diagnostic cystoscopy is the only definitive diagnostic tool through histopathological examination of the resected tissues. Proper sampling should include the underlying muscularis propria. Transurethral resection of bladder tumor (TURBT) can miss proper muscle layer sampling in 25% of invasive cancer leading to under-staging. TURBT depends on the surgeon's experience, so the tumor-free rate varies widely .
Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans. Treatment methods aim at preserving the quality of life and reduce stage progression. The usual conservative approach in MIBC is a trimodal treatment (TMT). It consists of a transurethral resection of the bladder tumor (TURBT) as complete as possible, followed by concomitant radiotherapy (RT) and chemotherapy (CT). Response to radiotherapy and chemotherapy is then assessed by cystoscopy and biopsies. Planned surgery is proposed to non-responders and additional chemotherapy and RT with careful regular endoscopic examination is performed in responders .
Except for the incomplete selective bladder preservation against radical excision (SPARE) trial, there is no large and meaningful randomized trial comparing radical cystectomy and TMT .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled clinical trial comparing radical cystectomy and trimodal therapy, included adult patients with cT2N0M0 muscle invasive localized urinary bladder TCC presented to our urology clinic.
| Arm | Type | Receives |
|---|---|---|
| Radical Cystectomy group | Active comparator | Other: Radical cystectomy with pelvic lymphadenectomyGtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group. |
| Trimodal therapy group | Active comparator | Radiation: Trimodal therapyGroup B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults of any gender, aged 18 years or older.
- Histologically confirmed urothelial (transitional cell) carcinoma (TCC) of the urinary bladder, clinical stage T2N0M0, diagnosed through:
Key exclusion criteria (14 listed)
- Evidence of significant nodal involvement on imaging.
- Presence of carcinoma in situ (CIS).
- Hydronephrosis attributed to the bladder tumor.
- Non-TCC histology of bladder cancer.
- TCC with atypical histological variants including:
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 |
|---|---|---|
| Radical cystectomy with pelvic lymphadenectomyGtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group. | Other | Radical Cystectomy group |
| Trimodal therapyGroup B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY | Radiation | Trimodal therapy group |
Primary outcome
Overall survival
Time frame: 3 years
Disease free survival
Time frame: 3 years
Cancer specific survival
Time frame: 3 years
1 secondary outcome
Complications of intervention
Time frame: 3 years
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 30 Jul 2025.
- Results publication: PubMed 30763236Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.
- Results publication: PubMed 30280456Imai S, Yamada T, Kasashi K, Niinuma Y, Kobayashi M, Iseki K. Construction of a risk prediction model of vancomycin-associated nephrotoxicity to be used at the time of initial therapeutic drug monitoring: A data mining analysis using a decision tree model. J Eval Clin Pract. 2019 Feb;25(1):163-170. doi: 10.1111/jep.13039. Epub 2018 Oct 2.
- Results publication: PubMed 29281848Ritch CR, Balise R, Prakash NS, Alonzo D, Almengo K, Alameddine M, Venkatramani V, Punnen S, Parekh DJ, Gonzalgo ML. Propensity matched comparative analysis of survival following chemoradiation or radical cystectomy for muscle-invasive bladder cancer. BJU Int. 2018 May;121(5):745-751. doi: 10.1111/bju.14109. Epub 2018 Jan 22.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Lotfy Ghazy, Lecturer of Urology study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical cystectomy with pelvic lymphadenectomy and Trimodal therapy in people with Transitional Cell Bladder Cancer and Cystectomy, run by Ain Shams 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 14 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 30 Jul 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 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.
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?
Overall survival (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT07043790, 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 30 Jul 2025.