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

S

Sara Mahmoud Ahmed Mahmoud

Status

Not yet enrolling

Conditions

Bladder Urothelial Carcinoma

Treatments

Drug: Chemotherapy with platine

Study type

Observational

Funder types

Other

Identifiers

NCT06727214
Survival of NAC in MIBC

Details and patient eligibility

About

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 .

Full 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.

Enrollment

87 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

87 participants in 1 patient group

MIBC patients who received NAT
Description:
muscle invasive bladder cancer patients who received neoadjuvant chemotherapy
Treatment:
Drug: Chemotherapy with platine

Trial contacts and locations

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Central trial contact

Sara Mahmoud Ahmed, resident; Rehab Farouk Mohamed, professor

Data sourced from clinicaltrials.gov

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