Clinical trial methodology in rare gynecologic tumor research: Strategies for success.
作者： Jubilee Brown , R. Wendel Naumann , William E. Brady , Robert L. Coleman , Kathleen N. Moore
DOI: 10.1016/J.YGYNO.2018.04.008
关键词:
摘要: Abstract Background Performing clinical trials in rare gynecologic cancers presents specific challenges. Strategies for improving accrual and modifications trial design are outlined. Methods The literature was reviewed order to present statistical designs pertinent the study of cancers. experience Gynecologic Oncology Group/NRG is outlined as it relates cancer development. Results Significant progress has been made studying tumors, both nationally oncology, but challenges inherent uncommon diseases remain. Important components these include establishing standard care, utilizing appropriate effectively answer question trial, accurately estimating sample size, choosing modified realistic endpoints, avoiding pitfalls tumors. Adaptive important Conclusion effective must be implemented when designing patients.
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sci-hub.se 参考文章(25)
Isabelle Ray-Coquard, David M. Gershenson, How to Study Rare Gynecological Tumors: Trials or Registries? Springer London. pp. 111- 119 ,(2014) , 10.1007/978-0-85729-910-9_11
Jubilee Brown, William E. Brady, Julian Schink, Linda Van Le, Mario Leitao, S. Diane Yamada, Koen de Geest, David M. Gershenson, Efficacy and safety of bevacizumab in recurrent sex cord‐stromal ovarian tumors: Results of a phase 2 trial of the Gynecologic Oncology Group Cancer. ,vol. 120, pp. 344- 351 ,(2014) , 10.1002/CNCR.28421
Jonathan A. Ledermann, Daniela Luvero, Aaron Shafer, Dennis O’Connor, Giorgia Mangili, Michael Friedlander, Jacobus Pfisterer, Mansoor R. Mirza, Jae-Weon Kim, Jerome Alexandre, Amit Oza, Jubilee Brown, Gynecologic Cancer InterGroup (GCIG) Consensus Review for Mucinous Ovarian Carcinoma International Journal of Gynecological Cancer. ,vol. 24, pp. 14- 19 ,(2014) , 10.1097/IGC.0000000000000296
Brian M. Slomovitz, Karen H. Lu, Taren Johnston, Robert L. Coleman, Mark Munsell, Russell R. Broaddus, Cheryl Walker, Lois M. Ramondetta, Thomas W. Burke, David M. Gershenson, Judith Wolf, A phase 2 study of the oral mammalian target of rapamycin inhibitor, everolimus, in patients with recurrent endometrial carcinoma Cancer. ,vol. 116, pp. 5415- 5419 ,(2010) , 10.1002/CNCR.25515
Say-Beng Tan, Keith BG Dear, Paolo Bruzzi, David Machin, Strategy for randomised clinical trials in rare cancers BMJ. ,vol. 327, pp. 47- 49 ,(2003) , 10.1136/BMJ.327.7405.47
Michael S Lawrence, Petar Stojanov, Paz Polak, Gregory V Kryukov, Kristian Cibulskis, Andrey Sivachenko, Scott L Carter, Chip Stewart, Craig H Mermel, Steven A Roberts, Adam Kiezun, Peter S Hammerman, Aaron McKenna, Yotam Drier, Lihua Zou, Alex H Ramos, Trevor J Pugh, Nicolas Stransky, Elena Helman, Jaegil Kim, Carrie Sougnez, Lauren Ambrogio, Elizabeth Nickerson, Erica Shefler, Maria L Cortés, Daniel Auclair, Gordon Saksena, Douglas Voet, Michael Noble, Daniel DiCara, Pei Lin, Lee Lichtenstein, David I Heiman, Timothy Fennell, Marcin Imielinski, Bryan Hernandez, Eran Hodis, Sylvan Baca, Austin M Dulak, Jens Lohr, Dan-Avi Landau, Catherine J Wu, Jorge Melendez-Zajgla, Alfredo Hidalgo-Miranda, Amnon Koren, Steven A McCarroll, Jaume Mora, Ryan S Lee, Brian Crompton, Robert Onofrio, Melissa Parkin, Wendy Winckler, Kristin Ardlie, Stacey B Gabriel, Charles WM Roberts, Jaclyn A Biegel, Kimberly Stegmaier, Adam J Bass, Levi A Garraway, Matthew Meyerson, Todd R Golub, Dmitry A Gordenin, Shamil Sunyaev, Eric S Lander, Gad Getz, None, Mutational heterogeneity in cancer and the search for new cancer-associated genes Nature. ,vol. 499, pp. 214- 218 ,(2013) , 10.1038/NATURE12213
Thomas J. Herzog, Ronald D. Alvarez, Angeles Secord, Barbara A. Goff, Robert S. Mannel, Bradley J. Monk, Robert L. Coleman, SGO guidance document for clinical trial designs in ovarian cancer: A changing paradigm Gynecologic Oncology. ,vol. 135, pp. 3- 7 ,(2014) , 10.1016/J.YGYNO.2014.08.004
Michel Adamina, George Tomlinson, Ulrich Guller, Bayesian statistics in oncology: a guide for the clinical investigator Cancer. ,vol. 115, pp. 5371- 5381 ,(2009) , 10.1002/CNCR.24628
Stephen M. Ansell, Richard M. Goldberg, Daniel J. Sargent, Hui Tang, Nathan R. Foster, Axel Grothey, Comparison of Error Rates in Single-Arm Versus Randomized Phase II Cancer Clinical Trials Journal of Clinical Oncology. ,vol. 28, pp. 1936- 1941 ,(2010) , 10.1200/JCO.2009.25.5489
John Farley, William E Brady, Vinod Vathipadiekal, Heather A Lankes, Robert Coleman, Mark A Morgan, Robert Mannel, S Diane Yamada, David Mutch, William H Rodgers, Michael Birrer, David M Gershenson, Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study Lancet Oncology. ,vol. 14, pp. 134- 140 ,(2013) , 10.1016/S1470-2045(12)70572-7