NCT01096368 · BASELINE

Baseline characteristics

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma · Source last updated 2026-04-30

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

denoms

counts
group Id
BG000
value
37
group Id
BG001
value
167
group Id
BG002
value
163
group Id
BG003
value
63
group Id
BG004
value
49
group Id
BG005
value
479
units
Participants

groups

description
Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Arm I: Observation
description
Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
id
BG001
title
Arm II: Randomized to Radiation With Maintenance Chemotherapy
description
Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
id
BG002
title
Arm III: Randomized to Radiation Only
description
Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
id
BG003
title
Arm IV: Nonrandomly Assigned to Arm II Treatment
description
Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered
id
BG004
title
Not Ependymoma or Withdrew Before Radiation
description
Total of all reporting groups
id
BG005
title
Total

measures

classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
164
group Id
BG002
value
159
group Id
BG003
value
62
group Id
BG004
value
48
group Id
BG005
value
469
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
1
group Id
BG004
value
1
group Id
BG005
value
10
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
1.8
upper Limit
19.4
value
8.8
group Id
BG001
lower Limit
1.0
upper Limit
19.8
value
4.4
group Id
BG002
lower Limit
1.0
upper Limit
21.0
value
4.5
group Id
BG003
lower Limit
1.0
upper Limit
18.9
value
4.2
group Id
BG004
lower Limit
1.2
upper Limit
18.2
value
7.5
group Id
BG005
lower Limit
1.0
upper Limit
21.0
value
5.2
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
78
group Id
BG002
value
68
group Id
BG003
value
23
group Id
BG004
value
27
group Id
BG005
value
214
title
Female
measurements
group Id
BG000
value
19
group Id
BG001
value
89
group Id
BG002
value
95
group Id
BG003
value
40
group Id
BG004
value
22
group Id
BG005
value
265
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
37
group Id
BG002
value
30
group Id
BG003
value
11
group Id
BG004
value
11
group Id
BG005
value
94
title
Hispanic or Latino
measurements
group Id
BG000
value
29
group Id
BG001
value
119
group Id
BG002
value
129
group Id
BG003
value
47
group Id
BG004
value
35
group Id
BG005
value
359
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
4
group Id
BG003
value
5
group Id
BG004
value
3
group Id
BG005
value
26
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
0
group Id
BG001
value
2
group Id
BG002
value
3
group Id
BG003
value
0
group Id
BG004
value
1
group Id
BG005
value
6
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
4
group Id
BG004
value
0
group Id
BG005
value
16
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
5
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
6
group Id
BG001
value
21
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
7
group Id
BG005
value
50
title
Black or African American
measurements
group Id
BG000
value
24
group Id
BG001
value
113
group Id
BG002
value
119
group Id
BG003
value
43
group Id
BG004
value
30
group Id
BG005
value
329
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
4
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
2
group Id
BG005
value
7
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
22
group Id
BG002
value
21
group Id
BG003
value
9
group Id
BG004
value
9
group Id
BG005
value
66
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
31
group Id
BG001
value
142
group Id
BG002
value
132
group Id
BG003
value
44
group Id
BG004
value
42
group Id
BG005
value
391
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
17
group Id
BG002
value
15
group Id
BG003
value
10
group Id
BG004
value
3
group Id
BG005
value
50
title
Canada
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
7
group Id
BG002
value
14
group Id
BG003
value
8
group Id
BG004
value
4
group Id
BG005
value
33
title
Australia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
5
title
New Zealand
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
37
group Id
BG001
value
167
group Id
BG002
value
163
group Id
BG003
value
63
group Id
BG004
value
49
group Id
BG005
value
479
units
Participants

groups

description
Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Arm I: Observation
description
Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
id
BG001
title
Arm II: Randomized to Radiation With Maintenance Chemotherapy
description
Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
id
BG002
title
Arm III: Randomized to Radiation Only
description
Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
id
BG003
title
Arm IV: Nonrandomly Assigned to Arm II Treatment
description
Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered
id
BG004
title
Not Ependymoma or Withdrew Before Radiation
description
Total of all reporting groups
id
BG005
title
Total

measures

classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
164
group Id
BG002
value
159
group Id
BG003
value
62
group Id
BG004
value
48
group Id
BG005
value
469
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
1
group Id
BG004
value
1
group Id
BG005
value
10
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
1.8
upper Limit
19.4
value
8.8
group Id
BG001
lower Limit
1.0
upper Limit
19.8
value
4.4
group Id
BG002
lower Limit
1.0
upper Limit
21.0
value
4.5
group Id
BG003
lower Limit
1.0
upper Limit
18.9
value
4.2
group Id
BG004
lower Limit
1.2
upper Limit
18.2
value
7.5
group Id
BG005
lower Limit
1.0
upper Limit
21.0
value
5.2
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
78
group Id
BG002
value
68
group Id
BG003
value
23
group Id
BG004
value
27
group Id
BG005
value
214
title
Female
measurements
group Id
BG000
value
19
group Id
BG001
value
89
group Id
BG002
value
95
group Id
BG003
value
40
group Id
BG004
value
22
group Id
BG005
value
265
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
37
group Id
BG002
value
30
group Id
BG003
value
11
group Id
BG004
value
11
group Id
BG005
value
94
title
Hispanic or Latino
measurements
group Id
BG000
value
29
group Id
BG001
value
119
group Id
BG002
value
129
group Id
BG003
value
47
group Id
BG004
value
35
group Id
BG005
value
359
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
4
group Id
BG003
value
5
group Id
BG004
value
3
group Id
BG005
value
26
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
0
group Id
BG001
value
2
group Id
BG002
value
3
group Id
BG003
value
0
group Id
BG004
value
1
group Id
BG005
value
6
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
4
group Id
BG004
value
0
group Id
BG005
value
16
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
5
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
6
group Id
BG001
value
21
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
7
group Id
BG005
value
50
title
Black or African American
measurements
group Id
BG000
value
24
group Id
BG001
value
113
group Id
BG002
value
119
group Id
BG003
value
43
group Id
BG004
value
30
group Id
BG005
value
329
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
4
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
2
group Id
BG005
value
7
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
22
group Id
BG002
value
21
group Id
BG003
value
9
group Id
BG004
value
9
group Id
BG005
value
66
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
31
group Id
BG001
value
142
group Id
BG002
value
132
group Id
BG003
value
44
group Id
BG004
value
42
group Id
BG005
value
391
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
17
group Id
BG002
value
15
group Id
BG003
value
10
group Id
BG004
value
3
group Id
BG005
value
50
title
Canada
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
7
group Id
BG002
value
14
group Id
BG003
value
8
group Id
BG004
value
4
group Id
BG005
value
33
title
Australia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
5
title
New Zealand
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

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Preserved source evidence · Not medical advice