Skip to content

Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06727214
Acronym
AssiutU
Enrollment
87
Registered
2024-12-10
Start date
2025-11-04
Completion date
2026-12-01
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Urothelial Carcinoma

Keywords

survival benefits, neoadjuvant CTH, bladder cancer

Brief 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 . 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.

Interventions

medical records that patients received neoadjuvant systemic chemotherapy platine based

Sponsors

Sara Mahmoud Ahmed Mahmoud
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer3 to 6 months (from previous medical reports )evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria

Secondary

MeasureTime frameDescription
Disease free survival (DFS)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.
overall survival (OS)from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeksOS: defined as the length of time from either the date of diagnosis or the start of treatment for cancer, that patients are still alive.
Progression Free Survival ( PFS )an average 2 yearsthe average lenght of time after the start of treatment in which a person is alive and their cancer does not grow or spread

Contacts

Primary ContactSara Mahmoud Ahmed, resident
sara.mahmoud371998@gmail.com+201118247266
Backup ContactRehab Farouk Mohamed, professor
foroukrehab@aun.edu.eg+201004435644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026