SWOG clinical trial number
S1011

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

Closed
Phase
Accrual
100%
Abbreviated Title
Muscle-Invasive Bladder Ca, Std vs Ext PLND, Ph III
Activated
08/01/2011
Closed
04/15/2017
Participants
Limited: Credentialed Surgeons Listed on S1011 Abstract Page

Research committees

Genitourinary Cancer

Treatment

Surgery

Eligibility Criteria Expand/Collapse

Pts must have histologically-proven T2, T3 or T4a bladder ca requiring radical cystectomy. Pt must not have clinical stage consistent with low-risk of node mets (CIS only, T1) nor T4b (fixed lesion). Pts with predominantly small cell, squamous cell, or adenocarcinoma histologies are not eligible. There must be plans for cystectomy and LND w/in 28 days of registration by study-specific credentialed surgeon. Laparoscopic surgery is not allowed. No prior partial cystectomy for invasive bladder ca. Pts must not have received any prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised. Prior neoadj chemo ok if completed w/in 70 days prior to planned cystectomy and pt recovered from associated toxicities. No prior pelvic irradiation. No evidence of visceral or nodal mets proximal to common iliac bifurcation on CXR or CT of abd and abd/pelvic CT or MRI w/in 56 days prior to reg. Bili, SGOT, SGPT, alk phos w/in IULN w/in 28 days prior to reg. These lab values may be greater than IULN if met dx excluded w/appropriate imaging. Prestudy physical exam & med hx w/in 28 days prior to reg. Pt must be offered specimen banking. Pt must have Zubrod PS of 0-2 and be medically suitable for cystectomy. Pt must not be pregnant or nursing at the time of radical cystectomy and women must have agreed to use effective contraceptive method. No other prior malignancy as outlined in 5.3e.

Publication Information Expand/Collapse

2019

2015

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: SWOG S1011 (NCT #01224665)

S Lerner;C Tangen;R Svatek;T Koppie;A Alva;F La Rosa;S Pal;S Daneshmand;CPN Dinney;AS Kibel;K Pohar;DJ Canter;W Kassouf;R Bangs;IM Thompson Journal of Urology, Vol. 193, Issue 4, e807 [abst MP65-02]; American Urological Association (May 15-19, 2015, New Orleans), moderated poster presentation;

2014

Pre-randomization factors and utilization of neoadjuvant chemotherapy in a clinical trial of extended vs. standard pelvic lymphadenectomy at the time of radical cystectomy for bladder cancer

SP Lerner;H Li;R Svatek;T Koppie;A Alva;F LaRosa;R Bangs;S Pal;S Daneshmand;A Kibel;D Canter;C Tangen;IM Thompson Journal of Clinical Oncology 32(suppl 4; abstr 295); ASCO Genitourinary Cancers Symposium (Jan 30-Feb 1, 2014, San Francisco , poster

Other Clinical Trials

SWOG Clinical Trial Number
S1806

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.

Research Committee(s)
Genitourinary Cancer
Activated
04/19/2019
Accrual
2%
Open
Phase
III
SWOG Clinical Trial Number
S1802
SWOG Clinical Trial Number
CTSU/EA8153