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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04319263
Enrollment
1600
Registered
2020-03-24
Start date
2020-03-01
Completion date
2020-03-18
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

DRUGinduction regimen of intravesical BCG

intravesical instillation of 6 weekly doses of BCG

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
one year Recurrence rateone yearrecurrence rate at 1 year after induction BCG
one year progression rateone yearprogression rate at 1 year after induction BCG

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026