NCT00027846 · STUDY IN CONTEXT

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.

The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.

→

secondary · POSTED

Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.

All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.

→

secondary · POSTED

The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.

Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.

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secondary · POSTED

EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.

Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.

→

secondary · POSTED

EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.

Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.

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secondary · POSTED

Documented and analyzed qualitatively and quantitatively.

All eligible patients in the study were included.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-central-nervous-system-tumors
nct id: NCT00027846
trial label: Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0000
source section id
NCT00027846-om-0000
source outcome index
0
endpoint
Event-free Survival
endpoint definition
Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
time origin
Up to 5 years after completion of study treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0001
source section id
NCT00027846-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.
time origin
Up to 5 years after completion of study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0002
source section id
NCT00027846-om-0002
source outcome index
2
endpoint
Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
endpoint definition
The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
time origin
At the time of second surgery
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0003
source section id
NCT00027846-om-0003
source outcome index
3
endpoint
Event-free Survival (EFS)
endpoint definition
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
time origin
At 5 years since the time of radiation therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0004
source section id
NCT00027846-om-0004
source outcome index
4
endpoint
Event-free Survival (EFS)
endpoint definition
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.
time origin
At 5 years since the time of radiation therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0005
source section id
NCT00027846-om-0005
source outcome index
5
endpoint
Local Control and Patterns of Failure
endpoint definition
Documented and analyzed qualitatively and quantitatively.
time origin
Up to 5 years after completion of study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients in the study were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0000
arm key
OG000
arm label
GTR1 Differentiated Histology Supratentorial (Group 1)
regimen
Patients undergo observation.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0000
arm key
OG001
arm label
Radiation (Group 2)
regimen
Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
analyzed count
281
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0000
arm key
OG002
arm label
Sub-Total Resection Any Histology or Location (STR) (Group 3)
regimen
Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0001
arm key
OG000
arm label
GTR1 Differentiated Histology Supratentorial (Group 1)
regimen
Patients undergo observation.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0001
arm key
OG001
arm label
Radiation (Group 2)
regimen
Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
analyzed count
281
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0001
arm key
OG002
arm label
Sub-Total Resection Any Histology or Location (STR) (Group 3)
regimen
Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0002
arm key
OG000
arm label
Sub-Total Resection Any Histology or Location (STR) (Group 3)
regimen
Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0003
arm key
OG000
arm label
Differentiated Ependymoma
regimen
Differentiated ependymoma:tumor pathology by central review.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0003
arm key
OG001
arm label
Anaplastic Ependymoma
regimen
Anaplastic ependymoma:tumor pathology by central review.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0004
arm key
OG000
arm label
Differentiated Ependymoma
regimen
Differentiated ependymoma:tumor pathology by central review.
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0004
arm key
OG001
arm label
Anaplastic Ependymoma
regimen
Anaplastic ependymoma:tumor pathology by central review.
analyzed count
124
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
outcome key
om-0005
arm key
OG000
arm label
GTR1 Differentiated Histology Supratentorial (Group 1)
regimen
Patients undergo observation.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00027846-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
harm key
EG000
source section id
NCT00027846-ae
event group key
EG000
event group label
Radiation (Group 2)
serious affected
38
serious at risk
281
other affected
52
other at risk
281
frequency threshold
5
collection period
Source null
event definition
All eligible patients were considered in the evaluation of adverse events. 281 eligible patients were in the group 2 and 64 eligible patients were in the group 3. GTR1 Differentiated Histology Supratentorial (Group 1) is an observation arm. Adverse events were not collected for the " GTR1 Differential Histology Supratentorial(Group 1)" observation arm..
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00027846
harm key
EG001
source section id
NCT00027846-ae
event group key
EG001
event group label
Sub-Total Resection Any Histology or Location (STR) (Group 3)
serious affected
55
serious at risk
64
other affected
27
other at risk
64
frequency threshold
5
collection period
Source null
event definition
All eligible patients were considered in the evaluation of adverse events. 281 eligible patients were in the group 2 and 64 eligible patients were in the group 3. GTR1 Differentiated Histology Supratentorial (Group 1) is an observation arm. Adverse events were not collected for the " GTR1 Differential Histology Supratentorial(Group 1)" observation arm..
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice