Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central

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

Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.

One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.

→

primary · POSTED

Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.

One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.

→

primary · POSTED

The number of patients who experience death that is considered to be primarily attributable to complications of treatment.

One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.

→

secondary · POSTED

Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.

68 eligible patients were evaluable

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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-embryonal-tumors-pediatric
nct id: NCT00653068
trial label: Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central
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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0000
source section id
NCT00653068-om-0000
source outcome index
0
endpoint
Event-free Survival
endpoint definition
Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
time origin
Up to 4 years after study enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.
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-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0001
source section id
NCT00653068-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.
time origin
Up to 4 years after study enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.
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-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0002
source section id
NCT00653068-om-0002
source outcome index
2
endpoint
Toxic Death
endpoint definition
The number of patients who experience death that is considered to be primarily attributable to complications of treatment.
time origin
During and after completion of study treatment up to 1 year after enrollment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.
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-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0003
source section id
NCT00653068-om-0003
source outcome index
3
endpoint
Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
endpoint definition
Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.
time origin
During protocol therapy up to 1 year after enrollment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
68 eligible patients were evaluable
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-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0000
arm key
OG000
arm label
Stratum I
regimen
Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
57
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0000
arm key
OG001
arm label
Stratum III
regimen
Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0001
arm key
OG000
arm label
Stratum I
regimen
Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
57
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0001
arm key
OG001
arm label
Stratum III
regimen
Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0002
arm key
OG000
arm label
Stratum I
regimen
Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
57
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0002
arm key
OG001
arm label
Stratum III
regimen
Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
outcome key
om-0003
arm key
OG000
arm label
All Patients
regimen
Experimental
analyzed count
68
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00653068-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-embryonal-tumors-pediatric
nct id
NCT00653068
harm key
EG000
source section id
NCT00653068-ae
event group key
EG000
event group label
Stratum I
serious affected
7
serious at risk
57
other affected
43
other at risk
57
frequency threshold
0
collection period
Source null
event definition
There were no patients enrolled in Stratum 2 or 4.
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-embryonal-tumors-pediatric
nct id
NCT00653068
harm key
EG001
source section id
NCT00653068-ae
event group key
EG001
event group label
Stratum III
serious affected
0
serious at risk
11
other affected
8
other at risk
11
frequency threshold
0
collection period
Source null
event definition
There were no patients enrolled in Stratum 2 or 4.
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