Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer (AssiutU)

September 29, 2025 updated by: Sara Mahmoud Ahmed Mahmoud

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rehab Farouk Mohamed, professor
  • Phone Number: +20102126709 +201004435644
  • Email: foroukrehab@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Age >18
  • histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )

Exclusion Criteria:

  • Non muscle invasive bladder cancer (NMIBC)
  • Metastatic patients
  • Patients treated with surgery firstly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MIBC patients who received NAT
muscle invasive bladder cancer patients who received neoadjuvant chemotherapy
Drug: Chemotherapy with platine
medical records that patients received neoadjuvant systemic chemotherapy platine based

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 to 6 months (from previous medical reports )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: thorough study completion (an average 1 year )
DFS the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
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
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.
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
the average lenght of time after the start of treatment in which a person is alive and their cancer does not grow or spread
an average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Mahmoud Ahmed Mahmoud

Investigators

  • Study Director: Rehab Farouk Mohamed, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 4, 2025

Primary Completion (Estimated)

November 4, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Survival of NAC in MIBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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