A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no R… (NCT03266900) | Clinical Trial Compass
TerminatedEarly Phase 1
A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
Stopped: Difficulties with accrual
Canada2 participantsStarted 2017-11-16
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wi…