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NCT Number: NCT06727214

Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

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 .

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Key information

Conditions

Bladder Urothelial Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy with platine

Drug

medical records that patients received neoadjuvant systemic chemotherapy platine based

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Farouk Mohamed, professor

CONTACT

[email protected]

+201004435644 ext. +20102126709

Sara Mahmoud Ahmed, resident

CONTACT

[email protected]

+201118247266 ext. +201021267096

Sponsors and collaborators

Lead sponsor

Sara Mahmoud Ahmed Mahmoud

Other

Registry information

Official study title

Survival Benefit of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer and Factors Affecting Its Response - Retrospective Study

Acronym: AssiutU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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