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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|ClinicalTrials.gov Identifier: NCT04319263|
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: induction regimen of intravesical BCG||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||March 18, 2020|
|Actual Study Completion Date :||March 18, 2020|
|Experimental: intermediate and high risk non muscle invasive bladder cancer||
Drug: induction regimen of intravesical BCG
intravesical instillation of 6 weekly doses of BCG
- one year Recurrence rate [ Time Frame: one year ]recurrence rate at 1 year after induction BCG
- one year progression rate [ Time Frame: one year ]progression rate at 1 year after induction BCG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319263
|Urology and Nephrology Center|
|Mansoura, Egypt, 35516|
|Principal Investigator:||Amr A Elsawy||Urology and Nephrology Center|