Phase 2 trial design in neuro-oncology revisited: a report from the RANO group

The Lancet Oncology
Evanthia GalanisSusan M Chang

Abstract

Advances in the management of gliomas, including the approval of agents such as temozolomide and bevacizumab, have created an evolving therapeutic landscape in glioma treatment, thus affecting our ability to reliably use historical controls to comparatively assess the activity of new therapies. Furthermore, the increasing availability of novel, targeted agents--which are competing for a small patient population, in view of the low incidence of primary brain tumours--draws attention to the need to improve the efficiency of phase 2 clinical testing in neuro-oncology to expeditiously transition the most promising of these drugs or combinations to potentially practice-changing phase 3 trials. In this report from the Response Assessment in Neurooncology (RANO) group, we review phase 2 trial designs that can address these challenges and capitalise on scientific and clinical advances in brain tumour treatment in neuro-oncology to accelerate and optimise the selection of drugs deserving further testing in phase 3 trials. Although there is still a small role for single-arm and non-comparative phase 2 designs, emphasis is placed on the potential role that comparative randomised phase 2 designs--such as screening designs, selection design...Continue Reading

Associated Clinical Trials

References

Mar 1, 1989·Controlled Clinical Trials·R Simon
Jul 1, 1989·European Journal of Cancer & Clinical Oncology·J TreatT Le Chevalier
Sep 1, 1986·Statistics in Medicine·J Herson, S K Carter
Dec 20, 1995·Journal of the National Cancer Institute·S KirbyG Cairncross
Mar 29, 2001·Statistics in Medicine·D J Sargent, R M Goldberg
Apr 18, 2001·Controlled Clinical Trials·D J SargentR M Goldberg
Mar 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Roger StuppSerge Leyvraz
Nov 15, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Gary L RosnerMark J Ratain
Jun 29, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Boris Freidlin, Richard Simon
Jul 7, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Evanthia GalanisUNKNOWN North Central Cancer Treatment Group
Sep 24, 2005·Health Services Research·P Adam KellyMarvella E Ford
Sep 30, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lawrence V RubinsteinMalcolm A Smith
Apr 26, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mark J RatainPeter J O'Dwyer
May 27, 2006·Journal of Biopharmaceutical Statistics·Paul GalloUNKNOWN PhRMA Working Group
Jun 20, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kathryn A CarsonEdward G Shaw
Dec 17, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Michael D PradosDaphne A Haas-Kogan
Dec 31, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Teri N KreislHoward A Fine
Mar 25, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Evanthia GalanisJan C Buckner
Jul 29, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stuart A GrossmanHoward A Fine
Sep 2, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Henry S FriedmanTimothy Cloughesy
Feb 4, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Wolfgang WickHoward A Fine
Feb 13, 2010·Neuro-oncology·Wenting WuMichael D Prados
Mar 10, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hui TangDaniel J Sargent
Apr 8, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Stuart A GrossmanUNKNOWN NABTT CNS Consortium
Apr 20, 2010·International Journal of Radiation Oncology, Biology, Physics·Victor A LevinEdward F Jackson
Dec 8, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Albert LaiTimothy Cloughesy
Feb 12, 2011·Neuro-oncology·David A ReardonPatrick Y Wen
Aug 14, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Tracy T BatchelorMartin van den Bent

❮ Previous
Next ❯

Citations

Nov 6, 2012·Current Oncology Reports·Derek R Johnson, Evanthia Galanis
Jul 17, 2013·Neuro-oncology·Brian M AlexanderDonald A Berry
Sep 1, 2014·Seminars in Oncology·Derek R Johnson, Evanthia Galanis
Nov 13, 2015·Future Oncology·Evidio Domingo-Musibay, Evanthia Galanis
Mar 19, 2016·Neuro-oncology·Mark R GilbertGlenn Lesser
Jan 1, 2015·Nature Reviews. Disease Primers·Michael WellerGuido Reifenberger
May 24, 2014·Contemporary Clinical Trials·Jie HuangGrazyna Lieberman
Aug 10, 2016·Current Treatment Options in Oncology·Hans-Georg Wirsching, Michael Weller
Oct 16, 2016·Magnetic Resonance Imaging Clinics of North America·Raymond Y Huang, Patrick Y Wen
Dec 30, 2016·Nature Reviews. Clinical Oncology·Guido ReifenbergerMichael Weller
Jun 18, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Marc C Chamberlain
Oct 11, 2017·Neuro-oncology·Evanthia GalanisUNKNOWN Alliance for Clinical Trials in Oncology and ABTC
Jun 24, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Patrick Y WenEudocia Q Lee
Nov 28, 2012·Nature Reviews. Clinical Oncology·Shota TanakaJorg Dietrich
Sep 25, 2018·Expert Opinion on Investigational Drugs·Juan Manuel SepúlvedaCarmen Balañá
Dec 1, 2015·Neuro-oncology Practice·Susan M ChangMartin J van den Bent
Jul 7, 2020·Neuro-oncology Practice·Shehryar SheikhMichael Vogelbaum
Jul 17, 2015·Neurosurgery·Fred G Barker
Sep 26, 2012·Current Opinion in Neurology·Nicholas Butowski, Susan M Chang
Dec 1, 2017·Neuro-oncology Practice·Jennie W TaylorMichael Prados
Aug 1, 2020·Frontiers in Neurology·Samantha E HoffmanWenya Linda Bi
Nov 16, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Tracy T BatchelorMichael Weller
Nov 16, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Mark R GilbertPatrick Y Wen
Apr 26, 2015·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Eudocia Q LeePatrick Y Wen
Jul 10, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·An-Chi TienNader Sanai
Jul 3, 2021·Current Treatment Options in Oncology·Eudocia Q Lee

❮ Previous
Next ❯

Related Concepts

Related Feeds

Arterial-Venous in Development & Disease

Arterial-venous development may play a crucial role in cardiovascular diseases. Here is the latest research.

Astrocytes

Astrocytes are glial cells that support the blood-brain barrier, facilitate neurotransmission, provide nutrients to neurons, and help repair damaged nervous tissues. Here is the latest research.

Angiogenesis Inhibitors to Treat Cancer

Cancer treatments including angiogenesis inhibitors prevent tumor cells from receiving nutrients and oxygen. Here is the latest research on angiogenesis inhibitors for the treatment of cancer.