A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder

August 13, 2022 updated by: Abdelrahman Atef Ali, Assiut University

In Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year.

About 25% of new diagnoses are muscle-invasive bladder cancer (MIBC), which carry a worse prognosis compared to non-muscle invasive disease.

Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines.

However, this is associated with a significant impact on quality of life.

The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival?

Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection, allowing the confirmation of CRT response pathologically. In the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence, suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT.

Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71511
        • Recruiting
        • Assuit university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient presented with bladder cancer whom are under treatment with multiple modalities such as endoscopic resection , chemotherapy , radiotherapy & partial cystectomy,

Description

Inclusion Criteria:

  1. Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface.
  2. Tumor at least 2 cm away from bladder neck or trigone.
  3. Clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after NAC at restaging TURBT (if done).
  4. Pathologically confirmed urothelial carcinoma.

Exclusion Criteria:

  1. Prescence of CIS.
  2. Presence of distant metastasis.
  3. Patients unfit for cisplatin-based chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tetra modal bladder preservation
Procedure: terta modal bladder preservation
neoadjuvant chemotherapy, partial cystectomy, radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local recurrence rate
Time Frame: the patient will be evaluted after partial cystectomy every 3 months for 2 years
the patient will be evaluated using MRI and cystoscopy
the patient will be evaluted after partial cystectomy every 3 months for 2 years
over active bladder symptom score
Time Frame: this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy
the patient will be asked about his symptoms using a questionnaire that is concerned about urgency , frequency , urge incontinence .
this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Diaa A Sayed, PhD, cheif of urological oncology department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Anticipated)

September 15, 2024

Study Completion (Anticipated)

September 15, 2024

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 13, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssuitUUro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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