Bladder Urothelial CarcinomaAssiutUNCT06727214
Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer
An observational study of Bladder Urothelial Carcinoma, run by Sara Mahmoud Ahmed Mahmoud at 1 site in Egypt.
Trial summary
Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma
- What is being tested?
- Chemotherapy with platine
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2025to 1 Jan 2027
- Phase
- Observational
- 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
Study population: Data Record of the patients will be reviewed for the following : *Clinical features:Age , Sex , Smoking ,base line renal function , comorbidities *HistoPathological features: Histological type of bladder cancer ,Carcinoma in situ,Lymphovascular invasion ( LVI) * Type of neoadjuvant chemotherapy received: Platinum based ( cisplatin, carboplatin) * Number of cycles . * Response to neoadjuvant chemotherapy : Assesed by radiological tools ( MRI , CT ) according to Recist criteria. * Follow up after finishing the course of neoadjuvant chemotherapy , using imaging and examination to detect the response and survival outcomes.
Who may be able to join
- Age >18
- histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )
Who cannot join
- Non muscle invasive bladder cancer (NMIBC)
- Metastatic patients
- Patients treated with surgery firstly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Benefit of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer and Factors Affecting Its Response - Retrospective Study
Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .
Read the detailed description
The goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients.
Clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic MIBC. Based on Level I evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the American Urologic Association (AUA), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Association of Urology (EAU) . In the Southwest Oncology Group (SWOG) Intergroup study, RC alone was compared with three cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. This randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront RC alone.
- Conditions
- Bladder Urothelial Carcinoma
- Being tested
- Chemotherapy with platine
- Keywords
- survival benefits, neoadjuvant CTH, bladder cancer
- 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.
Chemotherapy with platineDrug
medical records that patients received neoadjuvant systemic chemotherapy platine based
| Study group | Role | What they receive |
|---|---|---|
| MIBC patients who received NAT | muscle invasive bladder cancer patients who received neoadjuvant chemotherapy Receives: Drug: Chemotherapy with platine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer
evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria
Measured: 3 to 6 months (from previous medical reports )
Secondary outcomes (3)
Disease free survival (DFS)
DFS the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Measured: thorough study completion (an average 1 year )
overall survival (OS)
OS: defined as the length of time from either the date of diagnosis or the start of treatment for cancer, that patients are still alive.
Measured: from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks
Progression Free Survival ( PFS )
the average lenght of time after the start of treatment in which a person is alive and their cancer does not grow or spread
Measured: an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start4 Nov 2025
- Primary completion4 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bladder Urothelial CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Mahmoud Ahmed Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Mahmoud Ahmed Mahmoud, Assiut University
- Investigators
- Rehab Farouk Mohamed, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727214
- Sponsor's protocol ID
- Survival of NAC in MIBC
- Acronym
- AssiutU
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. doi: 10.1016/j.eururo.2005.04.006. Epub 2005 Apr 21.
PubMed 15939524Motterle G, Andrews JR, Morlacco A, Karnes RJ. Predicting Response to Neoadjuvant Chemotherapy in Bladder Cancer. Eur Urol Focus. 2020 Jul 15;6(4):642-649. doi: 10.1016/j.euf.2019.10.016. Epub 2019 Nov 8.
PubMed 31708469Daneshmand S, Nazemi A. Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer: Current Evidence. Eur Urol Focus. 2020 Jul 15;6(4):639-641. doi: 10.1016/j.euf.2020.04.011. Epub 2020 May 22.
PubMed 32451316Hu J, Chen J, Ou Z, Chen H, Liu Z, Chen M, Zhang R, Yu A, Cao R, Zhang E, Guo X, Peng B, Deng D, Cheng C, Liu J, Li H, Zou Y, Deng R, Qin G, Li W, Wang L, Chen T, Pei X, Gong G, Tang J, Othmane B, Cai Z, Zhang C, Liu Z, Zu X. Neoadjuvant immunotherapy, chemotherapy, and combination therapy in muscle-invasive bladder cancer: A multi-center real-world retrospective study. Cell Rep Med. 2022 Nov 15;3(11):100785. doi: 10.1016/j.xcrm.2022.100785. Epub 2022 Oct 19.
PubMed 36265483Yin M, Joshi M, Meijer RP, Glantz M, Holder S, Harvey HA, Kaag M, Fransen van de Putte EE, Horenblas S, Drabick JJ. Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis. Oncologist. 2016 Jun;21(6):708-15. doi: 10.1634/theoncologist.2015-0440. Epub 2016 Apr 6.
PubMed 27053504
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Benefit of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer and Factors Affecting Its Response - Retrospective Study
- ClinicalTrials.gov ID
- NCT06727214
- Acronym / sponsor ID
- AssiutU / Survival of NAC in MIBC
- Conditions
- Bladder Urothelial Carcinoma
- Keywords
- survival benefits, neoadjuvant CTH, bladder cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Sara Mahmoud Ahmed MahmoudUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 4 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Dec 2024 (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.
Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .
Detailed description
The goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients.
Clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic MIBC. Based on Level I evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the American Urologic Association (AUA), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Association of Urology (EAU) . In the Southwest Oncology Group (SWOG) Intergroup study, RC alone was compared with three cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. This randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront RC alone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIBC patients who received NAT | – | Drug: Chemotherapy with platinemuscle invasive bladder cancer patients who received neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data Record of the patients will be reviewed for the following : *Clinical features:Age , Sex , Smoking ,base line renal function , comorbidities *HistoPathological features: Histological type of bladder cancer ,Carcinoma in situ,Lymphovascular invasion ( LVI) * Type of neoadjuvant chemotherapy received: Platinum based ( cisplatin, carboplatin) * Number of cycles . * Response to neoadjuvant chemotherapy : Assesed by radiological tools ( MRI , CT ) according to Recist criteria. * Follow up after finishing the course of neoadjuvant chemotherapy , using imaging and examination to detect the response and survival outcomes.
Key inclusion criteria (2 listed)
- Age >18
- histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )
Key exclusion criteria (3 listed)
- Non muscle invasive bladder cancer (NMIBC)
- Metastatic patients
- Patients treated with surgery firstly
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 |
|---|---|---|
| Chemotherapy with platinemedical records that patients received neoadjuvant systemic chemotherapy platine based | Drug | MIBC patients who received NAT |
Primary outcome
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer
Time frame: 3 to 6 months (from previous medical reports )
evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria
3 secondary outcomes
Disease free survival (DFS)
Time frame: thorough study completion (an average 1 year )
overall survival (OS)
Time frame: from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks
Progression Free Survival ( PFS )
Time frame: an average 2 years
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 3 Nov 2026.
- Results publication: PubMed 15939524Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. doi: 10.1016/j.eururo.2005.04.006. Epub 2005 Apr 21.
- Results publication: PubMed 31708469Motterle G, Andrews JR, Morlacco A, Karnes RJ. Predicting Response to Neoadjuvant Chemotherapy in Bladder Cancer. Eur Urol Focus. 2020 Jul 15;6(4):642-649. doi: 10.1016/j.euf.2019.10.016. Epub 2019 Nov 8.
- Results publication: PubMed 32451316Daneshmand S, Nazemi A. Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer: Current Evidence. Eur Urol Focus. 2020 Jul 15;6(4):639-641. doi: 10.1016/j.euf.2020.04.011. Epub 2020 May 22.
- Results publication: PubMed 36265483Hu J, Chen J, Ou Z, Chen H, Liu Z, Chen M, Zhang R, Yu A, Cao R, Zhang E, Guo X, Peng B, Deng D, Cheng C, Liu J, Li H, Zou Y, Deng R, Qin G, Li W, Wang L, Chen T, Pei X, Gong G, Tang J, Othmane B, Cai Z, Zhang C, Liu Z, Zu X. Neoadjuvant immunotherapy, chemotherapy, and combination therapy in muscle-invasive bladder cancer: A multi-center real-world retrospective study. Cell Rep Med. 2022 Nov 15;3(11):100785. doi: 10.1016/j.xcrm.2022.100785. Epub 2022 Oct 19.
- Results publication: PubMed 27053504Yin M, Joshi M, Meijer RP, Glantz M, Holder S, Harvey HA, Kaag M, Fransen van de Putte EE, Horenblas S, Drabick JJ. Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis. Oncologist. 2016 Jun;21(6):708-15. doi: 10.1634/theoncologist.2015-0440. Epub 2016 Apr 6.
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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.
Rehab Farouk Mohamed, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Urothelial Carcinoma, run by Sara Mahmoud Ahmed Mahmoud 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 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 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?
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?
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?
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer (time frame: 3 to 6 months (from previous medical reports )). 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 NCT06727214, which also lists 5 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 3 Nov 2026.