Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
NCT05146635 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2022-01-11
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
Interventions
- DRUG
-
Intravesical Bcg
Patients will receive induction and maintenance BCG after complete TURBT.
- DRUG
-
Intravesical chemotherapy (epirubicin)
Patients will receive induction and maintenance epirubicin after complete TURBT.
Sponsors & Collaborators
-
Mansoura University
lead OTHER
Principal Investigators
-
Amr A Elsawy · Mansoura University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-01
- Primary Completion
- 2022-12-01
- Completion
- 2023-01-01
Countries
- Egypt
Study Locations
More Related Trials
-
Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
NCT04947059 ·Status: RECRUITING ·Phase: PHASE3
-
Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
NCT04740866 ·Status: UNKNOWN ·Phase: NA
-
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
NCT06696794 ·Status: RECRUITING ·Phase: PHASE3
-
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
NCT06462001 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers
NCT04723121 ·Status: COMPLETED ·Phase: NA
-
Intravesical Adjuvant Electromotive Mitomycin-C
NCT01920269 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
NCT02716961 ·Status: UNKNOWN ·Phase: NA
-
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)
NCT01799499 ·Status: WITHDRAWN ·Phase: NA
-
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
NCT05822934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins
NCT05969964 ·Status: RECRUITING
-
Intravesical Thermochemotherapy With Mitomycin-c
NCT03694535 ·Status: COMPLETED ·Phase: NA
-
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
NCT04164082 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Dose Dense MVAC for Muscle Invasive Bladder Cancer
NCT01031420 ·Status: COMPLETED ·Phase: PHASE2
-
Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder
NCT00343356 ·Status: COMPLETED ·Phase: PHASE2
-
Drug Screening Using IMD in Bladder Cancer
NCT06204614 ·Status: ENROLLING_BY_INVITATION ·Phase: EARLY_PHASE1
-
Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W
NCT06686381 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Intravesical Gem/Doce in Patients With NMIBC
NCT05644041 ·Status: RECRUITING ·Phase: PHASE2
-
A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
NCT03121768 ·Status: UNKNOWN
-
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
NCT03148158 ·Status: UNKNOWN
-
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
NCT03591367 ·Status: COMPLETED ·Phase: NA
-
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
NCT04386746 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
NCT02143804 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
NCT01438112 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
NCT04660344 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
NCT03661320 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3