Table 1 Clinical trial data analysed
From: Early toxicity predicts long-term survival in high-grade glioma
Study | Phase | Study question | BID RT | Concurrent systemic agent | Number of analysable subjects | BED | Acute neurological toxicity | Late neurological toxicity | Overall toxicity | Survival | Ref. |
---|---|---|---|---|---|---|---|---|---|---|---|
8302 | I/II | Hyperfractionated RT, dose escalation | Y | BCNU | 756 | 73.6–114.2 | 86 | 9 | Acceptable | HC | |
8409 | I/II | Role of AZQ | N | AZQ | 54 | 74–95 | 11 | 0 | NR | HC | (1998) |
9006 | III (R) | Conventional vs hyperfractionated RT | Y/N | BCNU | 693 | 100–100.8 | 28 | 15 | NR | HC | |
9305 | III (R) | Radiosurgical boost | N | BCNU | 187 | 100, >120 | 6 | 4 | Acceptable | HC | |
9411 | II | Dose escalation for small tumours | Y | BCNU | 105 | 98.1–108 | 5 | 3 | Acceptable | HC | |
9417 | II | Role of tirapazamine | N | Tirapazamine | 122 | 100 | 3 | 1 | More toxicities at higher dose | HC | |
9513 | II | Role of topotecan | N | Topotecan | 84 | 100 | 4 | 3 | Significant haematological toxicity | HC | |
9602 | II | Role of paclitaxel | N | Paclitaxel | 61 | 100 | 1 | 4 | Acceptable | HC | |
9710 | II | Role of beta-interferon | N | Beta-interferon | 55 | 100 | 1 | 2 | Acceptable | HC | |
9803 | I/II | Conventional fractionation, dose escalation | N | BCNU | 203 | 110–140 | 10 | 13 | Acceptable | HC | |
9806 | II | Role of thalidomide | N | Thalidomide | 125 | 100 | 19 | 12 | Acceptable | Slightly better than HC | |
0013 | II | Intra-tumoral bleomycin | N | Bleomycin | 14 | 100 | 1 | 4 | —a | —a | —a |
0021 | II | Role of tamoxifen | N | Tamoxifen | 75 | 100 | 2 | 4 | Acceptable | HC | |
0023 | II | Role of stereotactic RT boost | N | BCNU | 76 | 172 | 5 | 9 | Acceptable | HC |