Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

NCT ID: NCT06727214

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2026-12-01

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.

Conditions

Bladder Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

MIBC patients who received NAT

muscle invasive bladder cancer patients who received neoadjuvant chemotherapy

Chemotherapy with platine

Intervention Type: DRUG

medical records that patients received neoadjuvant systemic chemotherapy platine based

Interventions

Chemotherapy with platine

medical records that patients received neoadjuvant systemic chemotherapy platine based

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sara Mahmoud Ahmed Mahmoud

OTHER

Sponsor Role: lead

Responsible Party

Sara Mahmoud Ahmed Mahmoud

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rehab Farouk Mohamed, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Sara Mahmoud Ahmed, resident

Role: CONTACT

sara.mahmoud371998@gmail.com

+201118247266 ext. +201021267096

Rehab Farouk Mohamed, professor

Role: CONTACT

foroukrehab@aun.edu.eg

+201004435644 ext. +20102126709

References

Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. doi: 10.1016/j.eururo.2005.04.006. Epub 2005 Apr 21.

Reference Type: BACKGROUND

PMID: 15939524 (View on PubMed)

Motterle G, Andrews JR, Morlacco A, Karnes RJ. Predicting Response to Neoadjuvant Chemotherapy in Bladder Cancer. Eur Urol Focus. 2020 Jul 15;6(4):642-649. doi: 10.1016/j.euf.2019.10.016. Epub 2019 Nov 8.

Reference Type: BACKGROUND

PMID: 31708469 (View on PubMed)

Daneshmand S, Nazemi A. Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer: Current Evidence. Eur Urol Focus. 2020 Jul 15;6(4):639-641. doi: 10.1016/j.euf.2020.04.011. Epub 2020 May 22.

Reference Type: BACKGROUND

PMID: 32451316 (View on PubMed)

Hu J, Chen J, Ou Z, Chen H, Liu Z, Chen M, Zhang R, Yu A, Cao R, Zhang E, Guo X, Peng B, Deng D, Cheng C, Liu J, Li H, Zou Y, Deng R, Qin G, Li W, Wang L, Chen T, Pei X, Gong G, Tang J, Othmane B, Cai Z, Zhang C, Liu Z, Zu X. Neoadjuvant immunotherapy, chemotherapy, and combination therapy in muscle-invasive bladder cancer: A multi-center real-world retrospective study. Cell Rep Med. 2022 Nov 15;3(11):100785. doi: 10.1016/j.xcrm.2022.100785. Epub 2022 Oct 19.

Reference Type: BACKGROUND

PMID: 36265483 (View on PubMed)

Yin M, Joshi M, Meijer RP, Glantz M, Holder S, Harvey HA, Kaag M, Fransen van de Putte EE, Horenblas S, Drabick JJ. Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis. Oncologist. 2016 Jun;21(6):708-15. doi: 10.1634/theoncologist.2015-0440. Epub 2016 Apr 6.

Reference Type: BACKGROUND

PMID: 27053504 (View on PubMed)

Other Identifiers

Survival of NAC in MIBC

Identifier Type: -

Identifier Source: org_study_id