Table 1 Study characteristics reported in 11 trials of Gliadel wafers combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma
Clinical trial | Yr | Country | Sites | Study type Treatment years | Treatments/arms | ND HGG (n) | Gliadel wafer plus RT/TMZ (n) | GBM (n) | Other HGG (n) |
|---|---|---|---|---|---|---|---|---|---|
Aoki et al. [27] | 2014 | Japan | 10 | Phase I/II study 2009 to 2012 | Resection + Gliadel wafer + RT/TMZ | 16 | 16 | 9 | 7 |
Bock et al. [28] | 2010 | Germany | 7 | Retrospective analysis for safety risks 2005 to 2008 | Resection + Gliadel wafer + RT/TMZ | 44 | 44 | 44 | 0 |
Burri et al. [29] | 2015 | USA | 4 | Phase II/2003 to 2008 | Resection + Gliadel wafer + early TMZ (day 4) + RT/TMZ | 46 | 46 | 43 | 3 |
Duntze et al. [30] | 2012 | France | 17 | Prospective, observational 2007 to 2009 | Resection + Gliadel wafer + RT/TMZ | 92 | 65 | 74 | 18 |
McGirt et al. [31] | 2009 | USA | 1 | Retrospective analysis 1997 to 2006 | (1) Resection + Gliadel wafer + RT/TMZ | 33 | 33 | 33 | 0 |
(2) Resection + Gliadel wafer + RT | 78 | 78 | 0 | ||||||
(3) Resection/biopsy + RT/TMZ | 45 | 45 | 0 | ||||||
Menei et al. [32] | 2010 | France | 26 | Retrospective analysis 2005 to 2006 | (1) Resection + Gliadel wafer + RT/TMZ | 43 | 43 | 72 | 11 |
(2) Resection + Gliadel wafer + other regimens | 40 | ||||||||
Miglierini et al. [33] | 2012 | France | 1 | Retrospective analysis 2006 to 2010 | Resection + Gliadel wafer + RT/TMZ | 24 | 22 | 16 | 8 |
Noel et al. [34] | 2012 | France | 1 | Retrospective analysis 2007 to 2008 | (1) Resection + Gliadel wafer + RT/TMZ | 28 | 28 | 20 | 8 |
(2) Resection/biopsy + RT/TMZ | 37 |  | 16 | 21 | |||||
Pan et al. [35] | 2008 | USA | 1 | Retrospective analysis 2003 to 2005 | Resection + Gliadel wafer + RT/TMZ | 21 | 21 | 21 | 0 |
Pavlov et al. [36] | 2015 | France | 1 | Retrospective analysis 2004 to 2012 | Resection + Gliadel wafer + RT/TMZ | 83 | 61 | 83 | 0 |
Salvati et al. [37] | 2011 | Rome | 1 | Retrospective analysis 2006 to 2008 | Resection + Gliadel wafer + RT/TMZ | 32 | 32 | NA | NA |