Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activation

Canadian Cancer Trials Group BLC.1 (SWOG 1011) -- A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer -- was centrally activated in Canada on January 15, 2014.

The primary objective of the trial is to compare disease-free survival (DFS) in patients undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy.

Secondary Objectives are:
a. To compare overall survival (OS) in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy; and,
b. To evaluate operative time, whether or not nerve sparing was performed, intraoperative, peri-operative and 90 day morbidity and mortality, length of hospital stay, histology (pure urothelial versus mixed), lymph node counts and lymph node density, adjuvant chemotherapy received, and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well.

Total sample size is 620 patients.

Any centres interested in participating on this trial should contact Cathy Davidson, Study Coordinator, at cdavidson@ctg.queensu.ca or 613-533-6430.