Clinical trial · Interventional
A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
A Pilot, Single-centre, Randomized, 5-year, Parallel-group, Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
NCT03266900CI-TRIAL-00057926RESECTterminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties with accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6 weeks BCG instillation | Drug | — | UNRESOLVED |
| re-TURBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- re-TURBT
- description
- Patients in this arm will receive a 2nd TURBT within 4-6 weeks of initial TURBT
- interventionNames
- Procedure: re-TURBT
- type
- ACTIVE_COMPARATOR
- label
- 6 BCG instillations
- description
- Patients in this arm will not receive a 2nd TURBT, but will receive 6 instillations of BCG.
- interventionNames
- Drug: 6 weeks BCG instillation
Primary outcomes (1)
- measure
- 5 year Progression Free Survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Complete initial resection by a BCa-focused urologic oncologist; mandatory bladder detrusor muscle in the initial TURBT specimen and complete visible resection documented by the surgeon/OR staff by intra-operative photography. * Urothelial carcinoma as the predominant histology as determined by genitourinary specific pathologist (e.g. small (\<50%) components of small cell, squamous cell or adenocarcinoma are allowable). * Able and willing to consent. * ≥18 years old: BCa is primarily a disease of the elderly, thus we have elected to include healthy octogenarian/nonagenarian patients. Additionally, since a TURBT can be performed under general or spinal anesthesia, we feel that including these patients is acceptable. Exclusion Criteria: * Lymph node or distant metastases at initial presentation - determined on standard BCa staging evaluation with a CT-urogram of the abdomen/pelvis and/or a preoperative chest x-ray demonstrating pulmonary metastases. * Extensive NMIBC disease warranting immediate cystectomy. * Variant histology (not urothelial carcinoma) - ie. micropapillary, plasmacytoid, nested or sarcomatoid variants. * No muscularis propria (inadequate bladder staging) present in the initial TURBT specimen. * Initial TURBT demonstrating T1HG disease performed outside of study centre - as per study protocol, quality control of surgical performance for this trial requires the TURBT to be performed by an experienced BCa-dedicated surgeon. * Patients with severe comorbidities, including but not limited to: (i) previous stroke with persistent cognitive, motor, etc deficits; (ii) recent (\<6 months) myocardial infarction or current unstable angina; (iii) liver cirrhosis; (iv) severe chronic obstructive pulmonary disease (COPD)/respiratory disease. Patients must be suitable candidates for either spinal or general anesthesia. * Pregnancy or lactation.
References
Publications (0)
Data not yet available
No reference posted for this study.