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

(Curran et al, 1992)

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

(Scott et al, 1998a)

9305

III (R)

Radiosurgical boost

N

BCNU

187

100, >120

6

4

Acceptable

HC

(Souhami et al, 2004)

9411

II

Dose escalation for small tumours

Y

BCNU

105

98.1–108

5

3

Acceptable

HC

(Coughlin et al, 2000)

9417

II

Role of tirapazamine

N

Tirapazamine

122

100

3

1

More toxicities at higher dose

HC

(Del Rowe et al, 2000)

9513

II

Role of topotecan

N

Topotecan

84

100

4

3

Significant haematological toxicity

HC

(Fisher et al, 2002)

9602

II

Role of paclitaxel

N

Paclitaxel

61

100

1

4

Acceptable

HC

(Langer et al, 2001)

9710

II

Role of beta-interferon

N

Beta-interferon

55

100

1

2

Acceptable

HC

(Colman et al, 2006)

9803

I/II

Conventional fractionation, dose escalation

N

BCNU

203

110–140

10

13

Acceptable

HC

(Tsien et al, 2009)

9806

II

Role of thalidomide

N

Thalidomide

125

100

19

12

Acceptable

Slightly better than HC

(Yung et al, 2001)

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

(Robins et al, 2006)

0023

II

Role of stereotactic RT boost

N

BCNU

76

172

5

9

Acceptable

HC

(Cardinale et al, 2006)

  1. Abbreviations: AZQ=diaziquone; BCNU=carmustine; BED=biological-equivalent dose; BID=twice daily radiation; HC=historical controls; N=no; NR=not reported; R=randomised; RT=radiation therapy; Y=yes.
  2. aSmall study, never published.