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Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
induction regimen of intravesical BCG
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients for who complete TURBT, was carried out
  • Intermediate and high risk NMIBC.
  • Patients who received full induction BCG regimen (6 weekly doses).
  • Patients completed at least 12 months follow up after 3 months cystoscopy.

Exclusion Criteria:

  • Patients who received incomplete induction BCG regimen (less than 6 weekly doses)
  • Patients with incomplete (less than 12 months) follow up.

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intermediate and high risk non muscle invasive bladder cancer

Arm Description

Outcomes

Primary Outcome Measures

one year Recurrence rate
recurrence rate at 1 year after induction BCG
one year progression rate
progression rate at 1 year after induction BCG

Secondary Outcome Measures

Full Information

First Posted
March 20, 2020
Last Updated
March 24, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04319263
Brief Title
Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer
Official Title
Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This retrospective study aimed at assessment of different patterns (morphological and pathological) of tumor recurrence found at first evaluation after BCG induction therapy (3 months cystoscopy) for intermediate and high-risk NMIBC and its prognostic implications at a tertiary referral center.
Detailed Description
Bladder cancer (BCa) is the second most common genitourinary malignancy with approximately 75-85% of all patients with BCa present at diagnosis a non-muscle invasive bladder cancer (NMIBC) (Ta, T1 and Tis). Although NMIBC usually carries a favorable prognosis, there is a high risk of disease recurrence and a 10% to 20% risk of progression to muscle-invasive disease. The common treatment for intermediate- and high-risk patients is a transurethral resection followed by intravesical therapy with bacillus Calmette-Guerin (BCG), a non-specific immunotherapy that has remained the gold standard for 40 years. Over the last decades, several studies have confirmed the superiority of BCG over the combination of epirubicin and interferon, mitomycin C or epirubicin alone for prevention of tumor recurrence, in intermediate- and high-risk tumors. Despite wide acceptance of BCG intravesical therapy in intermediate and high risk NMIBC, there is still a controversy regarding the optimal protocol of administration. However, most of the guidelines have recommended an induction regimen of six weekly BCG instillations followed by maintenance instillation for at least 1 year. Complete response (CR) rates after an induction course of BCG for intermediate and high risk NMIBC are high and range from 50-70%. Tumor recurrence at first evaluation (3-months cystoscopy) after BCG induction therapy has been defined as a poor prognostic indicator in those groups of patients with an increased potential risk of disease recurrence and /or progression. Different patterns of tumor recurrence may be encountered at 3-mo cystoscopy during first evaluation after induction therapy either morphological (single tumor vs. multiple, <3 cm or more, site (? bladder neck involvement), papillary or non papillary) or histopathological (Ta vs. T1, concurrent CIS or not, tumor grade). To determine how to optimally manage those heterogeneous groups of patients, studying of the specific impact of different tumor characteristics on oncological outcomes is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intermediate and high risk non muscle invasive bladder cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
induction regimen of intravesical BCG
Intervention Description
intravesical instillation of 6 weekly doses of BCG
Primary Outcome Measure Information:
Title
one year Recurrence rate
Description
recurrence rate at 1 year after induction BCG
Time Frame
one year
Title
one year progression rate
Description
progression rate at 1 year after induction BCG
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients for who complete TURBT, was carried out Intermediate and high risk NMIBC. Patients who received full induction BCG regimen (6 weekly doses). Patients completed at least 12 months follow up after 3 months cystoscopy. Exclusion Criteria: Patients who received incomplete induction BCG regimen (less than 6 weekly doses) Patients with incomplete (less than 12 months) follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Elsawy
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer

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