NCT00686959 · BASELINE

Baseline characteristics

Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer · Source last updated 2016-06-28

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

denoms

counts
group Id
BG000
value
301
group Id
BG001
value
297
group Id
BG002
value
598
units
Participants

groups

description
Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
id
BG000
title
Arm A: Pemetrexed + Cisplatin and TRT
description
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
id
BG001
title
Arm B: Etoposide + Cisplatin and TRT
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.6
value
59.1
group Id
BG001
spread
9.4
value
58.5
group Id
BG002
spread
9.5
value
58.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
124
group Id
BG001
value
119
group Id
BG002
value
243
title
Female
measurements
group Id
BG000
value
177
group Id
BG001
value
178
group Id
BG002
value
355
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
12
group Id
BG002
value
27
title
African
categories
measurements
group Id
BG000
value
217
group Id
BG001
value
204
group Id
BG002
value
421
title
Caucasian
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
68
group Id
BG002
value
122
title
East Asian
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Hispanic
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native American
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
West Asian
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Missing (unknown)
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Argentina
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
76
group Id
BG002
value
134
title
United States
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
5
group Id
BG002
value
19
title
United Kingdom
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
title
Portugal
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
27
group Id
BG002
value
65
title
Spain
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
14
group Id
BG002
value
28
title
India
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
Greece
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
10
group Id
BG002
value
26
title
Canada
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
20
group Id
BG002
value
46
title
Netherlands
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Turkey
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
23
group Id
BG002
value
44
title
Belgium
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Ireland
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
145
group Id
BG002
value
293
title
0
categories
measurements
group Id
BG000
value
152
group Id
BG001
value
149
group Id
BG002
value
301
title
1
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
Missing
description
Eastern Cooperative Oncology Group (ECOG) performance status: 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as, light housework, office work
param Type
NUMBER
title
ECOG performance status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
140
group Id
BG001
value
142
group Id
BG002
value
282
title
Stage IIIA
categories
measurements
group Id
BG000
value
161
group Id
BG001
value
152
group Id
BG002
value
313
title
Stage IIIB
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Missing
description
Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIA - the cancer has spread to nearby tissue or spread to far away lymph nodes; Stage IIIB - cancer spread to opposite side of chest, more than one tumor within same lobe of lung.
param Type
NUMBER
title
Disease stage
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
226
group Id
BG001
value
226
group Id
BG002
value
452
title
Adenocarcinoma
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
21
group Id
BG002
value
37
title
Large cell carcinoma
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
48
group Id
BG002
value
107
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
param Type
NUMBER
title
Histology
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
58
group Id
BG002
value
108
title
Never smoked
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
38
group Id
BG002
value
80
title
Moderate smoker
categories
measurements
group Id
BG000
value
190
group Id
BG001
value
183
group Id
BG002
value
373
title
Heavy smoker
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
18
group Id
BG002
value
37
title
Missing
param Type
NUMBER
title
Smoking status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
241
group Id
BG002
value
491
title
Yes
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
56
group Id
BG002
value
107
title
No
description
Participant had a baseline Positron Emission Tomography (PET) scan for staging
param Type
NUMBER
title
Baseline PET scan
unit Of Measure
participants

population Description

All randomized participants

Complete source fields

denoms

counts
group Id
BG000
value
301
group Id
BG001
value
297
group Id
BG002
value
598
units
Participants

groups

description
Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
id
BG000
title
Arm A: Pemetrexed + Cisplatin and TRT
description
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
id
BG001
title
Arm B: Etoposide + Cisplatin and TRT
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.6
value
59.1
group Id
BG001
spread
9.4
value
58.5
group Id
BG002
spread
9.5
value
58.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
124
group Id
BG001
value
119
group Id
BG002
value
243
title
Female
measurements
group Id
BG000
value
177
group Id
BG001
value
178
group Id
BG002
value
355
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
12
group Id
BG002
value
27
title
African
categories
measurements
group Id
BG000
value
217
group Id
BG001
value
204
group Id
BG002
value
421
title
Caucasian
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
68
group Id
BG002
value
122
title
East Asian
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Hispanic
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native American
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
West Asian
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Missing (unknown)
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Argentina
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
76
group Id
BG002
value
134
title
United States
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
5
group Id
BG002
value
19
title
United Kingdom
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
title
Portugal
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
27
group Id
BG002
value
65
title
Spain
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
14
group Id
BG002
value
28
title
India
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
Greece
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
10
group Id
BG002
value
26
title
Canada
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
20
group Id
BG002
value
46
title
Netherlands
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Turkey
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
23
group Id
BG002
value
44
title
Belgium
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Ireland
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
145
group Id
BG002
value
293
title
0
categories
measurements
group Id
BG000
value
152
group Id
BG001
value
149
group Id
BG002
value
301
title
1
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
Missing
description
Eastern Cooperative Oncology Group (ECOG) performance status: 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as, light housework, office work
param Type
NUMBER
title
ECOG performance status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
140
group Id
BG001
value
142
group Id
BG002
value
282
title
Stage IIIA
categories
measurements
group Id
BG000
value
161
group Id
BG001
value
152
group Id
BG002
value
313
title
Stage IIIB
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Missing
description
Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIA - the cancer has spread to nearby tissue or spread to far away lymph nodes; Stage IIIB - cancer spread to opposite side of chest, more than one tumor within same lobe of lung.
param Type
NUMBER
title
Disease stage
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
226
group Id
BG001
value
226
group Id
BG002
value
452
title
Adenocarcinoma
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
21
group Id
BG002
value
37
title
Large cell carcinoma
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
48
group Id
BG002
value
107
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
param Type
NUMBER
title
Histology
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
58
group Id
BG002
value
108
title
Never smoked
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
38
group Id
BG002
value
80
title
Moderate smoker
categories
measurements
group Id
BG000
value
190
group Id
BG001
value
183
group Id
BG002
value
373
title
Heavy smoker
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
18
group Id
BG002
value
37
title
Missing
param Type
NUMBER
title
Smoking status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
241
group Id
BG002
value
491
title
Yes
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
56
group Id
BG002
value
107
title
No
description
Participant had a baseline Positron Emission Tomography (PET) scan for staging
param Type
NUMBER
title
Baseline PET scan
unit Of Measure
participants

population Description

All randomized participants

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Preserved source evidence · Not medical advice