From: Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis
Characteristics | Category or number | Total (n = 31), n (%) |
---|---|---|
Umbrella trial acronym and number of included sub-trials/arms | Lung-MAP | 5 (16.0a) |
BATTLE | 4 (12.9) | |
BATTLE-2 | 4 (12.9) | |
Cluster trial | 4 (12.9) | |
SUKSES | 4 (12.9) | |
VIKTORY | 4 (12.9) | |
FOCUS4 | 2 (6.5) | |
PICCOLO | 2 (6.5) | |
UmbHER1 | 2 (6.5) | |
Study classification | Sub-study | 19 (61.2a) |
Umbrella trial arm | 10 (32.3) | |
Sub-study arm | 2 (6.5) | |
Sub-trial/arm type | Experimental | 27 (87.1) |
Experimental—non-match | 2 (6.5) | |
Control group | 1 (3.2) | |
Placebo | 1 (3.2) | |
Therapy type | Targeted therapy | 21 (67.8a) |
Targeted therapy with chemotherapy | 8 (25.8) | |
Chemotherapy | 1 (3.2) | |
Placebo | 1 (3.2) | |
Publication year | 2019 | 14 (45.1a) |
2018 | 7 (22.6) | |
2016 | 4 (12.9) | |
2013 | 4 (12.9) | |
2011 | 2 (6.5) | |
Location | North America | 13 (42.0a) |
Asia | 12 (38.7) | |
Europe | 5 (16.1) | |
Australia | 1 (3.2) | |
Funding | Mixed | 21 (67.7) |
Private | 6 (19.4) | |
Public | 4 (12.9) | |
Sub-trial/arm status | Completed | 20 (64.5) |
Closed at interim analysis | 7 (22.5a) | |
Terminated | 2 (6.5) | |
Unknown | 2 (6.5) | |
Study definition | Phase II | 25 (80.6) |
Phase III | 4 (12.9) | |
Phase II/III | 2 (6.5) | |
Total number of investigational drugs | 1 drug | 22 (71.0) |
≥ 2 drugs | 9 (29.0) | |
Further studies recommended | No | 15 (48.3a) |
Not reported | 8 (25.8) | |
Yes | 6 (19.4) | |
Not applicable | 2 (6.5) | |
Enrolled patients, n (%) | 1637 (100) | Â |
Patients evaluable for toxicity, n (%)b | 1379 (84.2) | Â |
Patients evaluable for response, n (%)c | 1328 (81.1) | Â |
Male patients, n (%)d | 512 (31.3) | Â |
Median age at enrollment, n (%) of sub-studies/arms | Not reported | 13 (41.9) |
< 65 | 13 (41.9) | |
≥ 65 | 5 (16.2a) | |
Tumor type, n (%) of sub-studies/arms | Solid tumors | 31 (100) |
Hematological malignancies | 0 (0) | |
Stage of disease | Stage IIIB or IV or advanced or metastatic or relapsed | 30 (96.8) |
Early and locally advanced | 1 (3.2) | |
Performance status scale used, n (%) of sub-studies/arms | ECOG/WHO/Zubrod 0–1 | 9 (29.0) |
ECOG/WHO/Zubrod 0–2 | 22 (71.0) |