Clinical trial · Interventional
Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma
NCT07043790CI-TRIAL-00092828completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystectomy | — | UNRESOLVED | — |
| Radiation | — | UNRESOLVED | — |
| Transitional Cell Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical cystectomy with pelvic lymphadenectomy | Other | — | UNRESOLVED |
| Trimodal therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radical Cystectomy group
- description
- 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.
- interventionNames
- Other: Radical cystectomy with pelvic lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Trimodal therapy group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (3)
- RESULTKulkarni 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
- RESULTImai 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
- RESULTRitch 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