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
About this trial
This is an interventional treatment trial for Bladder Cancer
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.
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
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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