Neoadjuvant Chemoradiation for Resectable Glioblastoma

Summary

Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.

Timeline

Start

2020-04-01

Primary completion

2022-09-14

Completion

2022-09-14

Outcome

Outcome not reported

Stopped: “Suspended to identify a permanent PI at site level. Decision to Terminate was made on 7/29/25 because no other PI able to take on project.”

Publications

• Background Milano MT, Okunieff P, Donatello RS, Mohile NA, Sul J, Walter KA, Korones DN. Patterns and timing of recurrence after temozolomide-based chemoradiation for glioblastoma. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1147-55. doi: 10.1016/j.ijrobp.2009.09.018. Epub 2010 Mar 6.
• Background Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
• Background Yarbro JW. Future potential of adjuvant and neoadjuvant therapy. Semin Oncol. 1991 Dec;18(6):613-9. No abstract available.
• Background Filatova A, Acker T, Garvalov BK. The cancer stem cell niche(s): the crosstalk between glioma stem cells and their microenvironment. Biochim Biophys Acta. 2013 Feb;1830(2):2496-508. doi: 10.1016/j.bbagen.2012.10.008. Epub 2012 Oct 16.
• Background Rycaj K, Tang DG. Cancer stem cells and radioresistance. Int J Radiat Biol. 2014 Aug;90(8):615-21. doi: 10.3109/09553002.2014.892227. Epub 2014 Mar 7.

Drugs

Indications