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
SWOG-7303
SWOG Clinical Trial Number
SWOG-8221 (INT-0007)

Treatment of Advanced Bladder Cancer with Preoperative Irradiation and Radical Cystectomy versus Radical Cystectomy Alone

Research Committee(s)
Genitourinary Cancer
Activated
10/29/1982
Closed
11/15/1989
Accrual
81%
Closed
Published
SWOG Clinical Trial Number
SWOG-8216/38

Comparison of BCG Immunotherapy and Adriamycin for Superficial Bladder Cancer

Research Committee(s)
Genitourinary Cancer
Activated
12/01/1982
Closed
01/15/1987
Closed
Phase
III
Published