Table 1.
Trial Characteristics of Interventional Studies of Primary Malignant CNS Tumors Registered on ClinicalTrials.gov
| Number of Trials (%) | ||
|---|---|---|
| Phase (n = 2626) * | Early Phase 1 | 96 (3.7%) |
| Phase 1 | 760 (28.9%) | |
| Phase 1/Phase 2 | 377 (14.4%) | |
| Phase 2 | 1131 (43.1%) | |
| Phase 2/Phase 3 | 40 (1.5%) | |
| Phase 3 | 186 (7.1%) | |
| Phase 4 | 36 (1.4%) | |
| Recruitment status (n = 3038) | Completed | 1271 (41.9%) |
| Recruiting | 688 (22.7%) | |
| Terminated | 316 (10.4%) | |
| Active, not recruiting | 304 (10.0%) | |
| Unknown status | 223 (7.3%) | |
| Withdrawn | 124 (4.1%) | |
| Not yet recruiting | 83 (2.7%) | |
| Suspended | 23 (0.8%) | |
| Enrolling by invitation | 6 (0.2%) | |
| Primary purpose (n = 3019) | Treatment | 2590 (85.8%) |
| Diagnostic | 210 (7.0%) | |
| Supportive care | 93 (3.1%) | |
| Other | 38 (1.3%) | |
| Basic science | 34 (1.1%) | |
| Prevention | 30 (1.0%) | |
| Health services research | 12 (0.4%) | |
| Device feasibility | 7 (0.2%) | |
| Screening | 5 (0.2%) | |
| Has data monitoring committee (n = 2381) | TRUE | 1495 (62.8%) |
| FALSE | 886 (37.2%) | |
| FDA regulated drug or device (n = 1133) | TRUE | 718 (63.4%) |
| FALSE | 415 (36.6%) | |
| Results reported (n = 3038) | FALSE | 2514 (82.8%) |
| TRUE | 524 (17.3%) | |
| Single center study (n = 3038) | TRUE | 1654 (54.4%) |
| FALSE | 1384 (45.6%) | |
| One or more trial site in the United States (n = 2876) | TRUE | 2004 (69.7%) |
| FALSE | 872 (30.3%) | |
| Number of primary outcomes planned (n = 2823) | 1 | 1901 (67.3%) |
| 2 | 542 (19.2%) | |
| 3 | 175 (6.2%) | |
| 4 | 89 (3.2%) | |
| >=5 | 116 (4.7%) | |
| Blinding (n = 2838) | None (Open label) | 2618 (92.3%) |
| Single | 78 (2.8%) | |
| Double | 62 (2.2%) | |
| Triple | 41 (1.4%) | |
| Quadruple | 39 (1.4%) | |
| Intervention model (n = 2785) | Single-group assignment | 1806 (64.9%) |
| Parallel assignment | 824 (29.6%) | |
| Sequential assignment | 114 (4.1%) | |
| Crossover assignment | 36 (1.3%) | |
| Factorial assignment | 5 (0.2%) | |
| Randomization (n = 1287) | Nonrandomized | 656 (51.0%) |
| Randomized | 631 (49.0%) | |
| Intervention type (n = 3038) ** | Drug | 2333 (51.0%) |
| Radiation | 547 (12.0%) | |
| Biological | 478 (10.5%) | |
| Procedure | 457 (10.0%) | |
| Other | 453 (9.9%) | |
| Device | 173 (3.8%) | |
| Behavioral | 50 (1.1%) | |
| Diagnostic test | 30 (0.7%) | |
| Genetic | 24 (0.5%) | |
| Dietary supplement | 20 (0.4%) | |
| Combination product | 9 (0.2%) | |
| Top 30 conditions (n = 3038) *** | Glioblastoma | 1415 (47.4%) |
| Glioma | 1296 (43.4%) | |
| Astrocytoma | 384 (12.9%) | |
| Germ cell neoplasm | 253 (8.5%) | |
| Gliosarcoma | 242 (8.1%) | |
| Oligodendroglioma | 172 (5.8%) | |
| Medulloblastoma | 169 (5.7%) | |
| Central nervous system lymphoma | 147 (4.9%) | |
| Neuroectodermal neoplasm | 146 (4.9%) | |
| Ependymoma | 142 (4.8%) | |
| Meningioma | 152 (4.2%) | |
| Primitive neuro-ectodermal tumors (PNET) | 100 (3.4%) | |
| Pituitary neoplasm | 81 (2.71) | |
| Oligoastrocytoma | 78 (2.6%) | |
| Diffuse intrinsic pontine glioma (DIPG) | 64 (2.1%) | |
| Paraganglioma | 53 (1.8%) | |
| Nerve sheath neoplasm | 50 (1.7%) | |
| Teratoma | 46 (1.5%) | |
| Chordoma | 43 (1.4%) | |
| Germinoma | 43 (1.4%) | |
| Craniopharyngioma | 38 (1.3%) | |
| Pineoblastoma | 29 (1.0%) | |
| Choriocarcinoma | 21 (0.7%) | |
| Hemangiopericytoma | 21 (0.7%) | |
| Choroid plexus neoplasm | 19 (0.6%) | |
| Yolk sac neoplasm | 14 (0.5%) | |
| Xanthoastrocytoma | 10 (0.3%) | |
| Embryonal carcinoma | 9 (0.3%) | |
| Ganglioglioma | 8 (0.3%) | |
| Gliomatosis | 8 (0.3%) | |
| Top 10 trial site locations (n = 2876) | United States | 2004 (67.1%) |
| France | 256 (8.6%) | |
| Canada | 232 (7.8%) | |
| Germany | 181 (6.1%) | |
| China | 156 (5.2%) | |
| United Kingdom | 143 (4.8%) | |
| Netherlands | 131 (4.4%) | |
| Italy | 127 (4.3%) | |
| Spain | 126 (4.2%) | |
| Switzerland | 120 (4.0%) |
* n indicates the total number of trials reporting each trial characteristic listed;
** there may be multiple interventions reported per trial;
*** excluded top nonspecific categories such as “CNS neoplasms” and “brain neoplasms.”