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Table 2 Characteristics of the included studies

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)

 

Patients evaluable for toxicity, n (%)b

1379 (84.2)

 

Patients evaluable for response, n (%)c

1328 (81.1)

 

Male patients, n (%)d

512 (31.3)

 

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)

  1. ECOG Eastern Cooperative Oncology Group, WHO World Health Organization
  2. a The percentage was calculated by subtracting the remaining % values from 100%
  3. b The number of patients evaluable for toxicity was not reported in 8 sub-trials/arms
  4. c The number of patients evaluable for response was not reported in 1 sub-trial
  5. d Sex was not reported in 13 sub-trials/arms