Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study

NCT05626101 | Recruiting

• 1 other identifier: gemcitabin vs BCG
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

About 40%-80% of NMIBC recur within 6-12 months when managed with TURBT alone, and 10%-25% of the patient's progress to muscle invasive disease. Intravesical therapy enables delivery of high local concentrations of a therapeutic agent within the bladder, which could potentially destroy viable tumor cells that remain following TURBT

Conditions

Non-muscle-invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• Recurrence free survival (RFS)

  time from the commencement of induction treatment to recurrence. All recurrences will be confirmed by cystoscopic guided biopsy and histology.

  2 YEARS

• Progression free survival (PFS)

  progression in the initial tumour staging during follow-up cystoscopy. All progressions will be confirmed by histopathologic evaluation.

  2 YEARS

Secondary Outcomes (2)

• Side effects of intravesical gemcitabine injection.

  2 YEARS

• Side effects of intravesical BCG injection.

  2 YEARS

Study Arms (2)

Inravesical BCG

ACTIVE COMPARATOR

Intravsical induction and maintenance BCG injections.

Drug: BCG

Inravesical Gemcitabin

ACTIVE COMPARATOR

Intravsical induction and maintenance gemcitabin injections.

Drug: Gemcitabine

Interventions

BCG DRUG

Intravsical induction and maintenance BCG injections.

Inravesical BCG

Gemcitabine DRUG

Intravsical induction and maintenance gemcitabin injections.

Inravesical Gemcitabin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include moderate and high risk patients with NMIBC. Very high risk NMIBC patients, whom refusing radical cystectomy.

You may not qualify if:

• Active UTI.
• Suspected bladder perforation.
• Hematuria.
• Any contraindications for gemcitabin therapy; hypersenstivity, pregnancy, an infection, hemolytic uremic syndrome, , anemia, decreased blood platelets, low levels of a type of white blood cell called neutrophils.
• Patients whom previously received any inravesical therapy (e.g. prior BCG).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mohamed Fawzy Salman

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mohamed Fawzy Salman, MD

CONTACT

+201111788996; prof_mohamed_fawzy@yahoo.com

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: Director

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: January 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: October 11, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)