NCT01730937 · BASELINE

Baseline characteristics

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer · Source last updated 2026-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
92
group Id
BG001
value
85
group Id
BG002
value
177
units
Participants

groups

description
400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Sorafenib Alone
description
27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
id
BG001
title
SBRT Followed by Sorafenib
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
27
upper Limit
84
value
67
group Id
BG001
lower Limit
49
upper Limit
83
value
66
group Id
BG002
lower Limit
27
upper Limit
84
value
66
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
≤ 49 years
measurements
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
35
title
50 - 59 years
measurements
group Id
BG000
value
39
group Id
BG001
value
42
group Id
BG002
value
81
title
60 - 69 years
measurements
group Id
BG000
value
26
group Id
BG001
value
18
group Id
BG002
value
44
title
70 - 79 years
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
≥ 80 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
17
group Id
BG002
value
27
title
Female
measurements
group Id
BG000
value
82
group Id
BG001
value
68
group Id
BG002
value
150
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
54
group Id
BG001
value
47
group Id
BG002
value
101
title
Not Hispanic or Latino
measurements
group Id
BG000
value
32
group Id
BG001
value
36
group Id
BG002
value
68
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
23
group Id
BG001
value
18
group Id
BG002
value
41
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
58
group Id
BG001
value
59
group Id
BG002
value
117
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
41
group Id
BG001
value
47
group Id
BG002
value
88
title
0
measurements
group Id
BG000
value
44
group Id
BG001
value
33
group Id
BG002
value
77
title
1
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
2
description
0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, \<50% in bed during the day; 3 - Symptomatic, \>50% in bed, but not bedbound; 4 - Bedbound; 5 - Death
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
T1
measurements
group Id
BG000
value
17
group Id
BG001
value
19
group Id
BG002
value
36
title
T2
measurements
group Id
BG000
value
12
group Id
BG001
value
16
group Id
BG002
value
28
title
T3a
measurements
group Id
BG000
value
49
group Id
BG001
value
38
group Id
BG002
value
87
title
T3b
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
T4
description
Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
param Type
COUNT_OF_PARTICIPANTS
title
T Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
80
group Id
BG002
value
169
title
N0
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
N1
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
NX
description
Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes. (N0= no cancer in nearby lymph nodes; NX = cannot be measured.)
param Type
COUNT_OF_PARTICIPANTS
title
N Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
88
group Id
BG001
value
82
group Id
BG002
value
170
title
M0
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
M1
description
Metastasis stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the spread of the cancer to organs and tissues in other parts of the body. M0 = No distant metastasis; M1 = Distant metastasis; MX = Distant metastasis cannot be assessed.
param Type
COUNT_OF_PARTICIPANTS
title
M Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
64
group Id
BG002
value
133
title
5 (Grade A)
measurements
group Id
BG000
value
23
group Id
BG001
value
21
group Id
BG002
value
44
title
6 (Grade A)
description
Child Pugh Classification uses the following to determine liver function: 1) bilirubin levels; 2) albumin levels; 3) how quickly the blood clots (prothrombin time); 4) if there is fluid in the abdomen (ascites); and 5) if there is encephalopathy (liver disease has affected brain function). Each one of the previous is given a score: 5 (Grade A) and 6 (Grade A) mean the liver is working normally.
param Type
COUNT_OF_PARTICIPANTS
title
Child Pugh Score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
17
group Id
BG002
value
32
title
Intermediate (B)
measurements
group Id
BG000
value
77
group Id
BG001
value
68
group Id
BG002
value
145
title
Advanced (C)
description
Barcelona Clinic Liver Cancer (BCLC) staging system helps doctors determine the best treatment using 1) the number and size of tumors in the liver, 2) general health status or Zubrod performance status, and 3) liver function using Child-Pugh score. Intermediate(B): many tumors in liver, but overall status is good (Zubrod=0) and liver function is good with Child Pugh A or B. Advanced(C): cancer has spread, Zubrod=1 or 2, but liver function is still good with Child Pugh A or B.
param Type
COUNT_OF_PARTICIPANTS
title
BCLC Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
40
group Id
BG002
value
80
title
<10%
measurements
group Id
BG000
value
42
group Id
BG001
value
39
group Id
BG002
value
81
title
10-40%
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
title
>40%
description
The ratio of hepatocellular volume to the liver volume (as a percent).
param Type
COUNT_OF_PARTICIPANTS
title
Hepatocellular carcinoma (HCC) tumor volume / liver volume
unit Of Measure
Participants

population Description

Eligible participants

Complete source fields

denoms

counts
group Id
BG000
value
92
group Id
BG001
value
85
group Id
BG002
value
177
units
Participants

groups

description
400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Sorafenib Alone
description
27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
id
BG001
title
SBRT Followed by Sorafenib
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
27
upper Limit
84
value
67
group Id
BG001
lower Limit
49
upper Limit
83
value
66
group Id
BG002
lower Limit
27
upper Limit
84
value
66
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
≤ 49 years
measurements
group Id
BG000
value
15
group Id
BG001
value
20
group Id
BG002
value
35
title
50 - 59 years
measurements
group Id
BG000
value
39
group Id
BG001
value
42
group Id
BG002
value
81
title
60 - 69 years
measurements
group Id
BG000
value
26
group Id
BG001
value
18
group Id
BG002
value
44
title
70 - 79 years
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
≥ 80 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
17
group Id
BG002
value
27
title
Female
measurements
group Id
BG000
value
82
group Id
BG001
value
68
group Id
BG002
value
150
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
54
group Id
BG001
value
47
group Id
BG002
value
101
title
Not Hispanic or Latino
measurements
group Id
BG000
value
32
group Id
BG001
value
36
group Id
BG002
value
68
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
23
group Id
BG001
value
18
group Id
BG002
value
41
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
58
group Id
BG001
value
59
group Id
BG002
value
117
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
41
group Id
BG001
value
47
group Id
BG002
value
88
title
0
measurements
group Id
BG000
value
44
group Id
BG001
value
33
group Id
BG002
value
77
title
1
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
2
description
0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, \<50% in bed during the day; 3 - Symptomatic, \>50% in bed, but not bedbound; 4 - Bedbound; 5 - Death
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
T1
measurements
group Id
BG000
value
17
group Id
BG001
value
19
group Id
BG002
value
36
title
T2
measurements
group Id
BG000
value
12
group Id
BG001
value
16
group Id
BG002
value
28
title
T3a
measurements
group Id
BG000
value
49
group Id
BG001
value
38
group Id
BG002
value
87
title
T3b
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
T4
description
Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
param Type
COUNT_OF_PARTICIPANTS
title
T Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
80
group Id
BG002
value
169
title
N0
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
N1
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
NX
description
Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes. (N0= no cancer in nearby lymph nodes; NX = cannot be measured.)
param Type
COUNT_OF_PARTICIPANTS
title
N Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
88
group Id
BG001
value
82
group Id
BG002
value
170
title
M0
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
M1
description
Metastasis stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the spread of the cancer to organs and tissues in other parts of the body. M0 = No distant metastasis; M1 = Distant metastasis; MX = Distant metastasis cannot be assessed.
param Type
COUNT_OF_PARTICIPANTS
title
M Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
64
group Id
BG002
value
133
title
5 (Grade A)
measurements
group Id
BG000
value
23
group Id
BG001
value
21
group Id
BG002
value
44
title
6 (Grade A)
description
Child Pugh Classification uses the following to determine liver function: 1) bilirubin levels; 2) albumin levels; 3) how quickly the blood clots (prothrombin time); 4) if there is fluid in the abdomen (ascites); and 5) if there is encephalopathy (liver disease has affected brain function). Each one of the previous is given a score: 5 (Grade A) and 6 (Grade A) mean the liver is working normally.
param Type
COUNT_OF_PARTICIPANTS
title
Child Pugh Score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
17
group Id
BG002
value
32
title
Intermediate (B)
measurements
group Id
BG000
value
77
group Id
BG001
value
68
group Id
BG002
value
145
title
Advanced (C)
description
Barcelona Clinic Liver Cancer (BCLC) staging system helps doctors determine the best treatment using 1) the number and size of tumors in the liver, 2) general health status or Zubrod performance status, and 3) liver function using Child-Pugh score. Intermediate(B): many tumors in liver, but overall status is good (Zubrod=0) and liver function is good with Child Pugh A or B. Advanced(C): cancer has spread, Zubrod=1 or 2, but liver function is still good with Child Pugh A or B.
param Type
COUNT_OF_PARTICIPANTS
title
BCLC Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
40
group Id
BG002
value
80
title
<10%
measurements
group Id
BG000
value
42
group Id
BG001
value
39
group Id
BG002
value
81
title
10-40%
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
title
>40%
description
The ratio of hepatocellular volume to the liver volume (as a percent).
param Type
COUNT_OF_PARTICIPANTS
title
Hepatocellular carcinoma (HCC) tumor volume / liver volume
unit Of Measure
Participants

population Description

Eligible participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice