Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

Not yet recruiting

• Conditions: Bladder Urothelial Carcinoma
• Interventions: Drug: Chemotherapy with platine

• Registration Number: NCT06727214
• Lead Sponsor: Sara Mahmoud Ahmed Mahmoud

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study Start: 2024-12-04
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12-04
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIBC patients who received NAT	Chemotherapy with platine	muscle invasive bladder cancer patients who received neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer	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 Outcome Measures

Name	Time	Method
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 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.
Progression Free Survival ( PFS )	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
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.