A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
NCT03266900 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2022-04-20
Summary
The investigators would like to compare the progression free survival, overall survival, quality of life, and safety outcomes of patients receiving versus not receiving a 2nd transurethral resection of bladder tumor.
Conditions
- Bladder Cancer
- Bladder Urothelial Carcinoma
Interventions
- PROCEDURE
-
re-TURBT
2nd bladder biopsy within 4-6 weeks of initial biopsy
- DRUG
-
6 weeks BCG instillation
standard 6 weeks of BCG induction
Sponsors & Collaborators
-
Bladder Cancer Canada
collaborator UNKNOWN -
Canadian Urological Association
collaborator INDUSTRY -
Canadian Urologic Oncology Group
collaborator OTHER -
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Girish Kulkarni, MD PhD FRCSC · University Health Network - Princess Margaret Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-16
- Primary Completion
- 2021-10-04
- Completion
- 2021-10-04
Countries
- Canada
Study Locations
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