Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

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

Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.

181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.

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primary · POSTED

Percentage probability of being alive at 3 years following enrollment.

Source null

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secondary · POSTED

Calculated to quantify the treatment cost associated with this regimen.

182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint

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secondary · POSTED

The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy

182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint

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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-extracranial-germ-cell-tumors-pediatric
nct id: NCT00053352
trial label: Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0000
source section id
NCT00053352-om-0000
source outcome index
0
endpoint
Event-Free Survival (EFS)
endpoint definition
Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
time origin
3 Years after enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.
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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0001
source section id
NCT00053352-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
Percentage probability of being alive at 3 years following enrollment.
time origin
3 Years after enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0002
source section id
NCT00053352-om-0002
source outcome index
2
endpoint
Days Hospitalized for Patients Who Receive Chemotherapy
endpoint definition
Calculated to quantify the treatment cost associated with this regimen.
time origin
Up to 126 days after the start of chemotherapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint
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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0003
source section id
NCT00053352-om-0003
source outcome index
3
endpoint
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
endpoint definition
The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
time origin
Up to 126 days after the start of chemotherapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint
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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0000
arm key
OG000
arm label
Arm 1
regimen
Experimental
analyzed count
181
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00053352-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
Experimental
analyzed count
181
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00053352-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0001
arm key
OG001
arm label
Arm 2
regimen
No intervention
analyzed count
104
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00053352-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0002
arm key
OG000
arm label
Arm I
regimen
Experimental
analyzed count
182
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00053352-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
outcome key
om-0003
arm key
OG000
arm label
Arm I
regimen
Experimental
analyzed count
182
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00053352-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
harm key
EG000
source section id
NCT00053352-ae
event group key
EG000
event group label
Arm 2 (Observation)
serious affected
0
serious at risk
104
other affected
0
other at risk
104
frequency threshold
0
collection period
Source null
event definition
Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
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-extracranial-germ-cell-tumors-pediatric
nct id
NCT00053352
harm key
EG001
source section id
NCT00053352-ae
event group key
EG001
event group label
Arm I (Chemotherapy)
serious affected
0
serious at risk
182
other affected
78
other at risk
182
frequency threshold
0
collection period
Source null
event definition
Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
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