NCT00470366 · STUDY IN CONTEXT

Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Source null

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secondary · POSTED

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Source null

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secondary · POSTED

Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Source null

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secondary · POSTED

Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0

Source null

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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-ovarian-neoplasm
nct id: NCT00470366
trial label: Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated 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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0000
source section id
NCT00470366-om-0000
source outcome index
0
endpoint
Rate of Complete Response
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
time origin
3 years
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-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0001
source section id
NCT00470366-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
time origin
Up to 8 years
analysis role
secondary
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-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0002
source section id
NCT00470366-om-0002
source outcome index
2
endpoint
Percentage of Participants With Progression Free Survival
endpoint definition
Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
time origin
3 years
analysis role
secondary
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-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0003
source section id
NCT00470366-om-0003
source outcome index
3
endpoint
Number of Patients With Treatment Related Toxicity
endpoint definition
Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0
time origin
3 years
analysis role
secondary
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

arms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0000
arm key
OG000
arm label
Paclitaxel, Ifosfamide, and Cisplatin
regimen
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00470366-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0001
arm key
OG000
arm label
Paclitaxel, Ifosfamide, and Cisplatin
regimen
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00470366-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0002
arm key
OG000
arm label
Paclitaxel, Ifosfamide, and Cisplatin
regimen
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00470366-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
outcome key
om-0003
arm key
OG000
arm label
Paclitaxel, Ifosfamide, and Cisplatin
regimen
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00470366-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00470366
harm key
EG000
source section id
NCT00470366-ae
event group key
EG000
event group label
Paclitaxel, Ifosfamide, and Cisplatin
serious affected
34
serious at risk
60
other affected
60
other at risk
60
frequency threshold
5
collection period
Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
event definition
Source null
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