Status:
TERMINATED
A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Bladder Cancer Canada
Canadian Urological Association
Conditions:
Bladder Cancer
Bladder Urothelial Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
Brief 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 o...
Detailed Description
Background: Bladder cancer (BCa) is the 4th and 12th most common malignancies by incidence in Canadian men and women, respectively. In Canada, the lifetime probability of developing BCa is 1 in 27 men...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03266900
Start Date
November 16 2017
End Date
October 4 2021
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network
Toronto, Ontario, Canada, M5G2M9