Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer: A report from the Bladder Cancer Advocacy Network Clinical Trials Working Group

Matthew D. Galsky, Ryan Hendricks, Robert Svatek, Rick Bangs, Jean Hoffman-Censits, Jessica Clement, Robert Dreicer, Elizabeth Guancial, Noah Hahn, Seth P. Lerner, Peter H. O'Donnell, Diane Zipursky Quale, Arlene Siefker-Radtke, William Shipley, Guru Sonpavde, Daniel Vaena, Jacob Vinson, Jonathan Rosenberg

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1994-1998
Number of pages5
JournalCancer
Volume119
Issue number11
DOIs
StatePublished - Jun 1 2013
Externally publishedYes

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Urinary Bladder Neoplasms
Clinical Trials
Muscles
Research
Neoplasms
Registries
Censuses
Therapeutics
Communication

Keywords

  • bladder cancer
  • clinical trials
  • metastatic
  • urothelial cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer : A report from the Bladder Cancer Advocacy Network Clinical Trials Working Group. / Galsky, Matthew D.; Hendricks, Ryan; Svatek, Robert; Bangs, Rick; Hoffman-Censits, Jean; Clement, Jessica; Dreicer, Robert; Guancial, Elizabeth; Hahn, Noah; Lerner, Seth P.; O'Donnell, Peter H.; Quale, Diane Zipursky; Siefker-Radtke, Arlene; Shipley, William; Sonpavde, Guru; Vaena, Daniel; Vinson, Jacob; Rosenberg, Jonathan.

In: Cancer, Vol. 119, No. 11, 01.06.2013, p. 1994-1998.

Research output: Contribution to journalArticle

Galsky, MD, Hendricks, R, Svatek, R, Bangs, R, Hoffman-Censits, J, Clement, J, Dreicer, R, Guancial, E, Hahn, N, Lerner, SP, O'Donnell, PH, Quale, DZ, Siefker-Radtke, A, Shipley, W, Sonpavde, G, Vaena, D, Vinson, J & Rosenberg, J 2013, 'Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer: A report from the Bladder Cancer Advocacy Network Clinical Trials Working Group', Cancer, vol. 119, no. 11, pp. 1994-1998. https://doi.org/10.1002/cncr.27973
Galsky, Matthew D. ; Hendricks, Ryan ; Svatek, Robert ; Bangs, Rick ; Hoffman-Censits, Jean ; Clement, Jessica ; Dreicer, Robert ; Guancial, Elizabeth ; Hahn, Noah ; Lerner, Seth P. ; O'Donnell, Peter H. ; Quale, Diane Zipursky ; Siefker-Radtke, Arlene ; Shipley, William ; Sonpavde, Guru ; Vaena, Daniel ; Vinson, Jacob ; Rosenberg, Jonathan. / Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer : A report from the Bladder Cancer Advocacy Network Clinical Trials Working Group. In: Cancer. 2013 ; Vol. 119, No. 11. pp. 1994-1998.
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abstract = "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.",
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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

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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.

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