Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial

NCT05146635 | Unknown

• 1 other identifier: AE-12-2021
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective, single-center randomized controlled trial is to identify the optimal adjuvant intravesical therapy in patients with intermediate risk (IR) non muscle invasive bladder cancer by comparing two commonly utilized intravesical regimens; intravesical immunotherapy (BCG) and intravesical chemotherapy.

Conditions

Bladder Cancer

Keywords

Bladder cancer; Intravesical therapy; Recurrence; Progression

Outcome Measures

Primary Outcomes (2)

• Tumor recurrence rate

  Number of patient who will develop Recurrence rate during follow up

  2 years

• Tumor Progression rate

  Number of patient who will develop Progression rate during follow up

  2 years

Secondary Outcomes (1)

• Side effects from intravesical treatments

  2 years

Study Arms (2)

Intravesical immunotherapy (BCG) group

ACTIVE COMPARATOR

Drug: Intravesical Bcg

Intravesical chemotherapy (Epirubicin) group

ACTIVE COMPARATOR

Drug: Intravesical chemotherapy (epirubicin)

Interventions

Intravesical Bcg DRUG

Patients will receive induction and maintenance BCG after complete TURBT.

Intravesical immunotherapy (BCG) group

Intravesical chemotherapy (epirubicin) DRUG

Patients will receive induction and maintenance epirubicin after complete TURBT.

Intravesical chemotherapy (Epirubicin) group

Eligibility Criteria

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

You may qualify if:

• Adult patients (aged \>18 years)
• Patients with primary or recurrent papillary NMIBC.
• Complete TURBT.
• Patients with IR NMIBC confirmed by histopathology.

You may not qualify if:

• Inability to give informed consent.
• Patients with history of previous radiotherapy or systemic chemotherapy.
• Patients suffering from immuno-deficiency or other malignancies.
• Patients with history of hypersensitivity reaction to BCG or epirubicin.
• Examination under anesthesia (EUA) reveals palpable bladder mass.
• Patients with low or high risk NMIBC by histopathology

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence; Disease Progression

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Amr A Elsawy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Elsawy

CONTACT

01009428750; amrelsawy.unc@hotmail.com

Mahmoud Laymon

CONTACT

dr_mahmoudlaymon@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

EG (1)