SWOG clinical trial number
S0337

A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer

Closed
Phase
Accrual
100%
Abbreviated Title
Superficial Bladder, Post-TURBT Gemcitabine vs Saline, Ph III
Activated
07/15/2007
Closed
08/15/2012
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, Pathologists, Affiliates

Research committees

Genitourinary Cancer

Treatment

Gemcitabine hydrochloride Saline

Eligibility Criteria Expand/Collapse

Pts must clinically appear to have newly dx'd or recurrent Gr 1 or 2, Ta or T1 urothelial (TCC) bladder Ca; have had no more than 2 recurrences (other than index tumor) in the 18 mos preceding the index tumor's TURBT which are also Gr 1 or 2, Stage Ta or T1 w/out any previous TIS or Gr 3 cancer within 2 yrs preceeding index tumor TURBT or hx of muscularis propria invading; in their urologist's opinion not currently be a candidate for TX other than a TURBT. There must be plans for Pt to receive a TURBT w/in 28 working days after rand and TX w/in 3 hrs of TURBT. Pts must not have rec'd prev intravesical TX w/in 145 days prior to reg. Pts must have neg urine culture or negative UA w/in 28 days prior to reg. Pt must be offered opportunity to participate in specimen banking. Pt must have Zubrod PS of 0-1.

Publication Information Expand/Collapse

2022

Paper Alert—Implementing a New Standard of Care [Commentary]

E Messing Bladder Cancer, volume 8; issue 4

Risk-Based Assessment Of the Impact Of Intravesical Therapy on Recurrence-Free Survival Rate Following Resection of Suspected Low-grade, Non-muscle-invasive Bladder Cancer (NMIBC): A Southwest Oncology Groups (SWOG) S0337 Posthoc Analysis

N Corsi;E Messing;A Sood;J Keeley;C Bronchema;N Rakic;M Jamil;D Dalela;S Arora;A Piontkowski;S Majdalany;M Butaney;I Rakic;P Li;M Menon;C Rogers;F Abdollah Clinical Genitourinary Cancer Jun 25;S1558-7673(22)00140-9

PMid: PMID35871040

2021

ESTIMATING RECURRENCE-FREE SURVIVAL OF NON-MUSCLE INVASIVE BLADDER CANCER AFTER INTRAVESICAL THERAPY: A CLINICAL-BASED RECURSIVE PARTITION ANALYSIS

N Corsi;E Messing;A Sood;J Keeley;C Bronkema;N Rakic;D Dalela;M Jamil;C Rogers;F Abdollah Journal of Urology 2021;206(3):e304 - e304;

2018

Immediate post TURBT instillation of gemcitabine vs saline for suspected low grade bladder cancer: SWOG S0337

E Messing;C Tangen;SP Lerner;D Sahasrabudhe;T Koppie;DP Wood;PC Mack;R Svatek;C Evans;K Hafez;D Culkin;T Brand;L Karsh;J Holzbeierlein;SS Wilson;G Wu;M Plets;NJ Vogelzang;IM Thompson JAMA May 8;319(18):1880-1888

PMid: PMID29801011 | PMC number: PMC6583489

Immediate Post TURB Intravesical Gemcitabine: A cost comparison of SWOG S0337

J Gantz;E Noyes;CM Tangen;SP Lerner;IM Thompson;EM Messing Journal of Urology Vol. 199, No. 4S, Supplement, abst PD66-01; American Urological Association Annual Meeting (May 18-21, 2018, San Francisco, CA),

A Festschrift in Honor of Edward M. Messing, MD, FACS

J Joseph;RA Brasacchio;C Fung;J Reeder;K Bylund;D Sahasrabudhe;SY Yeh;A Ghazi;P Fultz;D Rubens;G Wu;E Singer;E Schwarz;S Mohile;J Mohler;D Theodorescu;YF Lee;P Okunieff;D McConkey;H Rashid;C Chang;Y Fradet;K Guru;J Kukreja;G Suffrin;Y Lotan;H Bailey;K Noyes;S Schwartz;K Rideout;G Bratslavsky;S Campbell;I Derweesh;P Abrahamsson;M Soloway;L Gomella;D Golijanin;R Svatek;T Frye;SP Lerner;G Palapattu;G Wilding;M Droller;D Trump Bladder Cancer Oct 3;4(Suppl 1):S1-S43

PMid: PMID30443561 | PMC number: PMC6226303

2017

A phase III blinded study of immediate post-TURBT instillation of gemcitabine versus saline in patients with newly diagnosed or occasionally recurring grade I/II non-muscle invasive cancer: SWOG S0337 (http://www.jurology.com/article/S0022-5347(17)39232-7/fulltext)

E Messing;C Tangen;D Sahasrabudhe;T Koppie;DP Wood;PC Mack;R Svatek;CP Evans;K Hafez;D Culkin;T Brand;LI Karsh;J Holzbeierlein;S Wilson;G Wu;M Plets;SP Lerner;N Vogelzang;I Thompson Journal of Urology Vol. 197, No. 4S, Supplement, PNFLBA-10; AUA Annual Meeting (May 12-16, 2017, Boston, MA), oral presentation

2016

Summary and recommendations from the National Cancer Institute's Clinical Trials planning meeting on novel therapeutics for non-muscle invasive bladder cancer

SP Lerner;DF Bajorin;CP Dinney;JA Efstathiou;S Groshen;NM Hahn;D Hansel;D Kwiatkowski;M O'Donnell;J Rosenberg;R Svatek;JS Abrams;H Al-Ahmadie;AB Apolo;J Bellmunt;M Callahan;EK Cha;C Drake;J Jarow;A Kamat;W Kim;M Knowles;B Mann;L Marchionni;D McConkey;L McShane;N Ramirez;A Sharabi;AH Sharpe;D Solit;CM Tangen;AT Amiri;E Van Allen;PJ West;JA Witjes;D Quale Bladder Cancer Apr 27;2(2):165-202

PMid: PMID27376138 | PMC number: PMC4927845

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