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

NCT07043790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-07-30

No results posted yet for this study

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

Interventions

OTHER

Radical cystectomy with pelvic lymphadenectomy

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.

RADIATION

Trimodal therapy

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed Lotfy Ghazy, Lecturer of Urology · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-04-03
Completion
2025-04-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043790 on ClinicalTrials.gov