TY - JOUR
T1 - Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer
T2 - A report from the Bladder Cancer Advocacy Network Clinical Trials Working Group
AU - Galsky, Matthew D.
AU - Hendricks, Ryan
AU - Svatek, Robert
AU - Bangs, Rick
AU - Hoffman-Censits, Jean
AU - Clement, Jessica
AU - Dreicer, Robert
AU - Guancial, Elizabeth
AU - Hahn, Noah
AU - Lerner, Seth P.
AU - O'Donnell, Peter H.
AU - Quale, Diane Zipursky
AU - Siefker-Radtke, Arlene
AU - Shipley, William
AU - Sonpavde, Guru
AU - Vaena, Daniel
AU - Vinson, Jacob
AU - Rosenberg, Jonathan
PY - 2013/6/1
Y1 - 2013/6/1
N2 - BACKGROUND There have been no improvements in the treatment of metastatic urothelial cancer in the past several decades. A census of contemporary clinical research in this disease was performed to identify potential barriers and opportunities. METHODS These authors performed a search for clinical trials exploring interventions in muscle-invasive and metastatic urothelial cancer, using the ClinicalTrials.gov registry. Data extracted from the registry included title, recruitment status, interventions, sponsor, phase, enrollment, study design, and study sites. RESULTS Among 120 eligible trials exploring interventions in muscle-invasive and metastatic urothelial cancer, 73% were phase 2 and 73% were nonrandomized. The majority (63%) involved treatment in the metastatic disease state. The median planned enrollment size per trial was 45 patients (interquartile range, 47 patients). The majority of trials (55%) involved ≤ 3 study sites. Trials most commonly explored interventions in the first-line metastatic (30%) or second-line metastatic (37%) settings. Targeted therapeutics were studied in 58% of the trials. Among 56 trials that completed enrollment, the median time to complete accrual was 50 months (range, 10-109 months), and these trials enrolled a median of 40 patients per trial (interquartile range, 44 patients). CONCLUSIONS The majority of contemporary clinical trials in muscle-invasive and metastatic urothelial cancer are small, nonrandomized, phase 2 trials involving 1 to 3 study sites. Enhanced communication and collaboration among the urothelial cancer community, and other stakeholders, is needed to facilitate the design and conduct of trials capable of expediting progress in this disease.
AB - BACKGROUND There have been no improvements in the treatment of metastatic urothelial cancer in the past several decades. A census of contemporary clinical research in this disease was performed to identify potential barriers and opportunities. METHODS These authors performed a search for clinical trials exploring interventions in muscle-invasive and metastatic urothelial cancer, using the ClinicalTrials.gov registry. Data extracted from the registry included title, recruitment status, interventions, sponsor, phase, enrollment, study design, and study sites. RESULTS Among 120 eligible trials exploring interventions in muscle-invasive and metastatic urothelial cancer, 73% were phase 2 and 73% were nonrandomized. The majority (63%) involved treatment in the metastatic disease state. The median planned enrollment size per trial was 45 patients (interquartile range, 47 patients). The majority of trials (55%) involved ≤ 3 study sites. Trials most commonly explored interventions in the first-line metastatic (30%) or second-line metastatic (37%) settings. Targeted therapeutics were studied in 58% of the trials. Among 56 trials that completed enrollment, the median time to complete accrual was 50 months (range, 10-109 months), and these trials enrolled a median of 40 patients per trial (interquartile range, 44 patients). CONCLUSIONS The majority of contemporary clinical trials in muscle-invasive and metastatic urothelial cancer are small, nonrandomized, phase 2 trials involving 1 to 3 study sites. Enhanced communication and collaboration among the urothelial cancer community, and other stakeholders, is needed to facilitate the design and conduct of trials capable of expediting progress in this disease.
KW - bladder cancer
KW - clinical trials
KW - metastatic
KW - urothelial cancer
UR - http://www.scopus.com/inward/record.url?scp=84878017704&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84878017704&partnerID=8YFLogxK
U2 - 10.1002/cncr.27973
DO - 10.1002/cncr.27973
M3 - Article
C2 - 23456777
AN - SCOPUS:84878017704
SN - 0008-543X
VL - 119
SP - 1994
EP - 1998
JO - Cancer
JF - Cancer
IS - 11
ER -