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CompletedNCT07402317Updated Feb 11, 2026

Trimodality Bladder Preservation

An interventional study of Transurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT in Bladder Cancer Treatment, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Dec 2018, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of this study is To evaluate the outcomes of patients with muscle invasive bladder cancer managed by trimodal therapy", Neoadjuvant chemotherapy( NAC) followed by Transurethral resection of the bladder tumor then Radiotherapy, for bladder preservation and capability to reach the goal of better quality of life, compared to radical cystectomy with assessment of factors that may predict treatment response, risk of recurrences and (disease- free and over all)survival of such patients...

Read the detailed description

Bladder Cancer (BC) is a worldwide health problem. It is the 7th most commonly diagnosed cancer in male population worldwide, whilst it drops to 11th for both sexes. Approximately 25% of newly diagnosed patients have muscle-invasive disease. Despite potentially curative radical surgery, approximately 50% of muscle invasive cases develop relapse within 2 years, and most of them die. Organ preservation has been the main goal of cancer care in the last two decades, yet it is not generally adopted for the cure of non-metastatic muscle invasive bladder cancer[1].

The standard of care for muscle invasive urothelial-cell carcinoma (UCC) of the bladder is radical cystectomy (RC). Radical surgery results in long-term survival rates of 40%-60% [2-4]. Sophisticated techniques for urinary diversion have been developed to improve patients' quality of life; however, this cannot substitute for the patient's original bladder [5].

Attempts to obtain bladder preservation are only justified when they have a high likelihood of achieving local cure with no compromise in survival rates. Transurethral resection of the bladder tumor (TURBT) alone, chemotherapy alone or radiation therapy alone provide inferior outcomes to radical cystectomy with only 20% to 40% local control rates in muscle invasive urothelial-cell carcinoma (UCC). Several groups have reported the value of combining all three modalities, with salvage cystectomy being reserved for patients with incomplete response or local relapse [6,7]. Bladder preservation approaches became increasingly favored, and became successful , essentially after the emergence of concurrent chemo-radiation protocols with cisplatin. The National Bladder Cancer Group first demonstrated the safety and efficacy of cisplatin, as a radiation sensitizer, in patients with MIBC who were unsuitable for cystectomy[8].

02

Conditions studied

  • Bladder Cancer Treatment
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In context

Lead sponsor

Al-Azhar University is the lead sponsor of 506 studies on the registry; 168 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: clinical case's of muscle invasive bladder cancer .T2 or more bladder cancer according to the American Joint Committee on Cancer (AJCC) staging system.

  • Age >18 years old. .Adequate bone marrow function. .Adequate renal functions. .Adequate hepatic functions.

Exclusion criteria:

.Distant metastases, pelvic lymph node metastasis. .Evidence of tumor-related hydronephrosis. .Severe irritative bladder symptoms.

  • Persistent infection. .Associated serious medical or psychiatric illness. .Prior or concurrent malignancy of any other site unless the patient was disease free for 5 years.

.Previous systemic chemotherapy or pelvic irradiation. .Pregnant or lactating female patients. .Each patient will give written informed consent before entering the study.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    T2 bladder cancer

    T2 patients

    Procedure: Transurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT

Interventions

  • ProcedureTransurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT

    Neo adjuvant chemotherapy followed by turbt followed by radiotherapy

06

What researchers measure

Primary outcomes

  1. Clinical ,radiological response , diagnostic cystoscopy and turbt biopsy either before and after neo adjuvant chemotherapy. Assessed response either complete, partial or progressive . according to tumor size,site ,stage, biopsy ( complete or incomplete

    Time frame: 4 years

07

Study locations

1 site
  • Azhar Assiut faculty of medicine
    Asyut, Egypt
08

References and documents

Publications

  • https://pubmed.ncbi.nlm.nih.gov/23485231/

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07402317
Lead sponsor
Al-Azhar University
Responsible party
Mahmoud Esmail Ali Abdelbaki (Assistant lecturer, Al-Azhar University) — Principal investigator
First posted
Feb 11, 2026
Start date
Dec 11, 2018
Primary completion
Sep 1, 2022
Completion
Jan 25, 2023
Last update
Feb 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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