Table 1.
Completed Trials of Radiosensitizers in the Temozolomide Era
First Author | NCT No. | Design | Patients, No. | Drug | Completed Study Drug + RT plus TMZ, % | Grade 3 Toxicity, n | Grade 4 Toxicity, n | Grade 5 Toxicity, n | Late-Grade 3 to 5 Toxicity, % | Delayed RT, % | 6-Mo PFS, % | Median PFS, mo | Median OS, mo |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Stupp, 200216 | Phase 2 single-arm | 64 | TMZ | 86 | 22 | 40 | – | – | 30 | – | – | 16 | |
Stupp, 20054 | NCT00006353 | Phase 3 randomized | 287 | TMZ | 85 | 7% grade 3/4 | – | – | 1 | 32 | 54 | – | 14.6 |
Brown, 200817 | NCT00039494 | Phase 2 single-arm | 97 | Erlotinib | 84 | 105 | 24 | 2 | – | – | – | 7.2 | 15.3 |
Prados, 200918 | NCT00187486 | Phase 2 single-arm | 65 | Erlotinib | – | 43 | 5 | 0 | – | – | 73 | 8.2 | 19.3 |
Peereboom, 201019 | NCT00274833 | Phase 2 single-arm | 28 | Erlotinib | 74 | 31 | 5 | 4 | – | – | 30 | 2.8 | 8.6 |
NCCTG N057K Ma, 201520 | NCT00553150 | Phase 1/2 single-arm | 100 | Everolimus | 78 | – | – | 1 | – | – | – | 6.4 | 15.8 |
RTOG 0913 Chinnaiyan, 201821 | NCT01062399 | Phase 1/2 randomized | 171 | Everolimus | – | 108 | 39 | 10 | – | – | – | 8.2 | 16.5 |
Krauze, 201522 | NCT00302159 | Phase 2 single-arm | 37 | Valproate | 67 | 16 | 6 | 0 | 223 | 0 | 70 | 10.5 | 29.6 |
Galanis, 201824 | NCT00731731 | Phase 1/2 single-arm | 107 | Vorinostat | – | 106 | 47 | 3 | – | – | – | 8.0 | 16.1 |
Butowski, 201125 | NCT00402116 | Phase 1/2 single-arm | 66 | Enzastaurin | – | 66% grade 3/4 | – | 5 | – | – | 65 | 8.4 | 17.3 |
Lee, 201526 | NCT00441142 | Phase 1/2 randomized | 76 | Vandenatib | 67 | 93 ≥ grade 3 | – | 1 | – | – | 58 | 7.7 | 16.6 |
Butowski, 200527 | Phase 2 single-arm | 61 | 13-cis-retinoic acid | 92 | 18 | 8 | 0 | – | – | 38 | 4.9 | 13.3 | |
Grossman, 200928 | Phase 2 single-arm | 72 | Talampanel | – | 38 | 15 | 1 | – | – | – | – | 18.3 | |
Kong, 201829 | NCT00998010 | Phase 2 single-arm | 24 | Bortezomib | – | 9 | 1 | 0 | – | – | 54 | 6.2 | 19.1 |
Abbreviations: NCCTG, North Central Cancer Treatment Group; NCT, national clinical trial; OS, overall survival; PFS, progression-free survival; RT, radiation; RTOG, Radiation Therapy Oncology Group; TMZ, temozolomide.