Literature DB >> 28388713

Point/counterpoint: randomized versus single-arm phase II clinical trials for patients with newly diagnosed glioblastoma.

Stuart A Grossman1, Karisa C Schreck1, Karla Ballman2, Brian Alexander3.   

Abstract

Entities:  

Keywords:  clinical trials; newly diagnosed glioblastoma; phase II; randomized; single-arm

Mesh：

Substances：

Year:  2017        PMID： 28388713      PMCID： PMC5464324          DOI： 10.1093/neuonc/nox030

Source DB:  PubMed          Journal:  Neuro Oncol        ISSN： 1522-8517            Impact factor:   12.300


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  41 in total

1.  Design issues of randomized phase II trials and a proposal for phase II screening trials.

Authors:  Lawrence V Rubinstein; Edward L Korn; Boris Freidlin; Sally Hunsberger; S Percy Ivy; Malcolm A Smith
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2.  STREPTOMYCIN treatment of pulmonary tuberculosis.

Authors: 
Journal:  Br Med J       Date:  1948-10-30

Review 3.  Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2.

Authors:  Brian M Alexander; Patrick Y Wen; Lorenzo Trippa; David A Reardon; Wai-Kwan Alfred Yung; Giovanni Parmigiani; Donald A Berry
Journal:  Neuro Oncol       Date:  2013-07-14       Impact factor: 12.300

4.  One-sample multiple testing procedure for phase II clinical trials.

Authors:  T R Fleming
Journal:  Biometrics       Date:  1982-03       Impact factor: 2.571

5.  Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States.

Authors:  Stuart A Grossman; Xiaobu Ye; Steven Piantadosi; Serena Desideri; Louis B Nabors; Myrna Rosenfeld; Joy Fisher
Journal:  Clin Cancer Res       Date:  2010-04-06       Impact factor: 12.531

6.  A randomized trial of bevacizumab for newly diagnosed glioblastoma.

Authors:  Mark R Gilbert; James J Dignam; Terri S Armstrong; Jeffrey S Wefel; Deborah T Blumenthal; Michael A Vogelbaum; Howard Colman; Arnab Chakravarti; Stephanie Pugh; Minhee Won; Robert Jeraj; Paul D Brown; Kurt A Jaeckle; David Schiff; Volker W Stieber; David G Brachman; Maria Werner-Wasik; Ivo W Tremont-Lukats; Erik P Sulman; Kenneth D Aldape; Walter J Curran; Minesh P Mehta
Journal:  N Engl J Med       Date:  2014-02-20       Impact factor: 91.245

7.  Correlation of single arm versus randomised phase 2 oncology trial characteristics with phase 3 outcome.

Authors:  Jose G Monzon; Annette E Hay; Gail T McDonald; Joseph L Pater; Ralph M Meyer; Eric Chen; Bingshu E Chen; Janet E Dancey
Journal:  Eur J Cancer       Date:  2015-08-31       Impact factor: 9.162

8.  Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial.

Authors:  Roger Stupp; Monika E Hegi; Thierry Gorlia; Sara C Erridge; James Perry; Yong-Kil Hong; Kenneth D Aldape; Benoit Lhermitte; Torsten Pietsch; Danica Grujicic; Joachim Peter Steinbach; Wolfgang Wick; Rafał Tarnawski; Do-Hyun Nam; Peter Hau; Astrid Weyerbrock; Martin J B Taphoorn; Chiung-Chyi Shen; Nalini Rao; László Thurzo; Ulrich Herrlinger; Tejpal Gupta; Rolf-Dieter Kortmann; Krystyna Adamska; Catherine McBain; Alba A Brandes; Joerg Christian Tonn; Oliver Schnell; Thomas Wiegel; Chae-Yong Kim; Louis Burt Nabors; David A Reardon; Martin J van den Bent; Christine Hicking; Andriy Markivskyy; Martin Picard; Michael Weller
Journal:  Lancet Oncol       Date:  2014-08-19       Impact factor: 41.316

9.  Participation in cancer clinical trials: race-, sex-, and age-based disparities.

Authors:  Vivek H Murthy; Harlan M Krumholz; Cary P Gross
Journal:  JAMA       Date:  2004-06-09       Impact factor: 56.272

10.  Do single-arm trials have a role in drug development plans incorporating randomised trials?

Authors:  Michael J Grayling; Adrian P Mander
Journal:  Pharm Stat       Date:  2015-11-26       Impact factor: 1.894
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  16 in total

1.  Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data.

Authors:  Steffen Ventz; Albert Lai; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Clin Cancer Res       Date:  2019-06-07       Impact factor: 12.531

2.  To randomize, or not to randomize, that is the question: using data from prior clinical trials to guide future designs.

Authors:  Alyssa M Vanderbeek; Steffen Ventz; Rifaquat Rahman; Geoffrey Fell; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Neuro Oncol       Date:  2019-10-09       Impact factor: 12.300

3.  How can we develop therapies for glioblastoma more efficiently? Randomized versus single-arm studies.

Authors:  Patrick Y Wen; Tao Jiang; David Schiff
Journal:  Neuro Oncol       Date:  2017-04-01       Impact factor: 12.300

4.  The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?

Authors:  Alyssa M Vanderbeek; Rifaquat Rahman; Geoffrey Fell; Steffen Ventz; Tianqi Chen; Robert Redd; Giovanni Parmigiani; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Neuro Oncol       Date:  2018-07-05       Impact factor: 12.300

5.  Platform trials arrive on time for glioblastoma.

Authors:  Brian M Alexander; Timothy F Cloughesy
Journal:  Neuro Oncol       Date:  2018-05-18       Impact factor: 12.300

Review 6.  Leveraging external data in the design and analysis of clinical trials in neuro-oncology.

Authors:  Rifaquat Rahman; Steffen Ventz; Jon McDunn; Bill Louv; Irmarie Reyes-Rivera; Mei-Yin C Polley; Fahar Merchant; Lauren E Abrey; Joshua E Allen; Laura K Aguilar; Estuardo Aguilar-Cordova; David Arons; Kirk Tanner; Stephen Bagley; Mustafa Khasraw; Timothy Cloughesy; Patrick Y Wen; Brian M Alexander; Lorenzo Trippa
Journal:  Lancet Oncol       Date:  2021-10       Impact factor: 41.316

Review 7.  Novel Clinical Trial Designs in Neuro-Oncology.

Authors:  Anurag Saraf; Lorenzo Trippa; Rifaquat Rahman
Journal:  Neurotherapeutics       Date:  2022-08-15       Impact factor: 6.088

8.  Current state of clinical trials in breast cancer brain metastases.

Authors:  Jawad Fares; Deepak Kanojia; Alex Cordero; Aida Rashidi; Jason Miska; Charles W Schwartz; Solomiia Savchuk; Atique U Ahmed; Irina V Balyasnikova; Massimo Cristofanilli; William J Gradishar; Maciej S Lesniak
Journal:  Neurooncol Pract       Date:  2019-02-11

9.  Long-term trends in glioblastoma survival: implications for historical control groups in clinical trials.

Authors:  Shehryar Sheikh; Tom Radivoyevitch; Jill S Barnholtz-Sloan; Michael Vogelbaum
Journal:  Neurooncol Pract       Date:  2019-10-01

Review 10.  An Overview of Phase 2 Clinical Trial Designs.

Authors:  Pedro A Torres-Saavedra; Kathryn A Winter
Journal:  Int J Radiat Oncol Biol Phys       Date:  2021-08-04       Impact factor: 7.038
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