Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06727214

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
Phase
Study type
Observational
Enrollment
87 (estimated)
Sponsor
Sara Mahmoud Ahmed Mahmoud · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGChemotherapy with platinemedical records that patients received neoadjuvant systemic chemotherapy platine based

Timeline

Start date
2025-11-04
Primary completion
2026-11-04
Completion
2026-12-01
First posted
2024-12-10
Last updated
2025-09-30

Regulatory

Source: ClinicalTrials.gov record NCT06727214. Inclusion in this directory is not an endorsement.