Table 1.
Characteristics for all phase II or III oncology trials conducted between 1990 and 2021 in JCOG
| Trials within planned accrual period | Trials without planned accrual period | P value | |||
|---|---|---|---|---|---|
| n = 47 | % | n = 152 | % | ||
| Phasea | |||||
| Phase II | 21 | 40% (2152) | 31 | 60% (31/52) | |
| Phase III | 26 | 18% (26/147) | 121 | 82% (121/147) | 0.002* |
| Randomization | |||||
| Yes | 20 | 15% (20/134) | 114 | 85% (114/134) | |
| No | 27 | 42% (27/65) | 38 | 58% (38/65) | <0.001* |
| Design type | |||||
| Superiority trials | 14 | 14% (14/97) | 83 | 86% (83/97) | |
| Noninferiority trials | 13 | 25% (13/52) | 39 | 75% (39/52) | |
| Othersb | 20 | 40% (20/50) | 30 | 60% (30/50) | 0.003* |
| No. of modality | |||||
| Single | 28 | 24% (28/116) | 88 | 76% (88/116) | |
| Multi | 19 | 23% (19/83) | 64 | 77% (64/83) | 0.867 |
| Intervention modality | |||||
| Surgery | |||||
| Yes | 20 | 28% (20/72) | 52 | 72% (52/72) | |
| No | 27 | 21% (27/127) | 100 | 79% (100/127) | 0.303 |
| Drug | |||||
| Yes | 38 | 23% (38/166) | 128 | 77% (128/166) | |
| No | 9 | 27% (9/33) | 24 | 73% (24/33) | 0.654 |
| Radiation | |||||
| Yes | 10 | 18% (10/56) | 46 | 82% (46/56) | |
| No | 37 | 26% (37/143) | 106 | 74% (106/143) | 0.269 |
| Examination | |||||
| Yes | 1 | 33% (1/3) | 2 | 67% (2/3) | |
| No | 46 | 23% (46/196) | 150 | 77% (150/196) | 0.557 |
| Competing trials at trial initiation | |||||
| Yes | 4 | 27% (4/15) | 11 | 73% (11/15) | |
| No | 43 | 23% (43/184) | 141 | 77% (141/184) | 0.756 |
| Intergroup trials | |||||
| Single | 40 | 23% (40/176) | 136 | 77% (136/176) | |
| Multi | 7 | 30% (7/23) | 16 | 70% (16/23) | 0.437 |
| Disease settings | |||||
| Metastatic | 11 | 21% (11/53) | 42 | 79% (42/53) | |
| Nonmetastatic | 36 | 25% (36/146) | 110 | 75% (110/146) | 0.706 |
| Cancer type | |||||
| Common solidc | 28 | 25% (28/114) | 86 | 75% (86/114) | |
| Rare solid or liquidc | 19 | 22% (19/85) | 66 | 78% (66/85) | 0.739 |
| >Planned sample size | |||||
| ≤100 | 20 | 42% (20/48) | 28 | 58% (28/48) | |
| 101–300 | 15 | 18% (15/84) | 69 | 82% (69/84) | |
| 300< | 12 | 18% (12/67) | 55 | 82% (55/67) | 0.005* |
| Planned accrual periods (years) | |||||
| ≤3 | 22 | 22% (22/98) | 76 | 78% (76/98) | |
| 3< | 25 | 25% (25/101) | 76 | 75% (76/101) | 0.741 |
| Planned institution number | |||||
| ≤30 | 21 | 28% (21/74) | 53 | 72% (53/74) | |
| 30< | 26 | 21% (26/125) | 99 | 79% (99/125) | 0.232 |
*P values were obtained from Fisher’s exact test or chi-squared test with a Bonferroni adjustment
aPhase II/III trials (13 trials) were included in phase III trials
bAll of them were phase II trials
cCommon solid cancer: lung, breast, gastric, colorectal, liver, pancreas, gallbladder, prostate. Rare solid or liquid cancer: brain, head and neck, esophageal, gynecologic, rectal, bladder, bone, skin, lymphoma