Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma

NCT07043790 | Completed DMC

• 1 other identifier: MD 183/2022
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is to compare the oncological outcome of trimodal therapy with bladder preservation using maximal resection with chemoradiation versus the standard radical cystectomy for muscle invasive transitional cell carcinoma of urinary bladder.

Conditions

Transitional Cell Bladder Cancer; Cystectomy; Radiation

Outcome Measures

Primary Outcomes (3)

• Overall survival

  3 years

• Disease free survival

  3 years

• Cancer specific survival

  3 years

Secondary Outcomes (1)

• Complications of intervention

  3 years

Study Arms (2)

Radical Cystectomy group

ACTIVE COMPARATOR

Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group.

Other: Radical cystectomy with pelvic lymphadenectomy

Trimodal therapy group

ACTIVE COMPARATOR

Group B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY

Radiation: Trimodal therapy

Interventions

Radical cystectomy with pelvic lymphadenectomy OTHER

Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group.

Radical Cystectomy group

Trimodal therapy RADIATION

Group B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY

Trimodal therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of any gender, aged 18 years or older.
• Histologically confirmed urothelial (transitional cell) carcinoma (TCC) of the urinary bladder, clinical stage T2N0M0, diagnosed through:
• Imaging (CT or MRI).
• Cystoscopy.
• Biopsy and histopathological examination of the tumor.

You may not qualify if:

• Evidence of significant nodal involvement on imaging.
• Presence of carcinoma in situ (CIS).
• Hydronephrosis attributed to the bladder tumor.
• Non-TCC histology of bladder cancer.
• TCC with atypical histological variants including:
• Micropapillary,
• Plasmacytoid,
• Anaplastic, or
• Sarcomatoid variants.
• High-grade non-muscle invasive bladder cancer (NMIBC).
• Patients unfit for surgery.
• Patients unfit for chemotherapy or radiotherapy.
• Refusal to undergo randomization.
• Prior chemotherapy or radiotherapy for bladder cancer.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AIn shams University

Cairo, Egypt

Location

Related Publications (3)

• Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.

  PMID: 30763236 RESULT

• Imai S, Yamada T, Kasashi K, Niinuma Y, Kobayashi M, Iseki K. Construction of a risk prediction model of vancomycin-associated nephrotoxicity to be used at the time of initial therapeutic drug monitoring: A data mining analysis using a decision tree model. J Eval Clin Pract. 2019 Feb;25(1):163-170. doi: 10.1111/jep.13039. Epub 2018 Oct 2.

  PMID: 30280456 RESULT

• Ritch CR, Balise R, Prakash NS, Alonzo D, Almengo K, Alameddine M, Venkatramani V, Punnen S, Parekh DJ, Gonzalgo ML. Propensity matched comparative analysis of survival following chemoradiation or radical cystectomy for muscle-invasive bladder cancer. BJU Int. 2018 May;121(5):745-751. doi: 10.1111/bju.14109. Epub 2018 Jan 22.

  PMID: 29281848 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Cystectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed Lotfy Ghazy, Lecturer of Urology

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology

Model Details: This is a randomized controlled clinical trial comparing radical cystectomy and trimodal therapy, included adult patients with cT2N0M0 muscle invasive localized urinary bladder TCC presented to our urology clinic.

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: April 1, 2021
• Primary Completion: April 3, 2025
• Study Completion: April 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

EG (1)