NCT00183820 · STUDY IN CONTEXT

Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

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. 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

Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.

1 patient was inevaluable.

→

secondary · POSTED

Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.

Source null

→

secondary · POSTED

Measuring Overall Survival

Source null

→

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-germ-cell-tumor
nct id: NCT00183820
trial label: Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
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.
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0000
source section id
NCT00183820-om-0000
source outcome index
0
endpoint
Tumor Response
endpoint definition
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
time origin
From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
1 patient was inevaluable.
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-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0001
source section id
NCT00183820-om-0001
source outcome index
1
endpoint
Progression-Free Survival
endpoint definition
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
time origin
Through study completion, about 9 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-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0002
source section id
NCT00183820-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Measuring Overall Survival
time origin
Through study completion, about 9 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-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0000
arm key
OG000
arm label
Paclitaxel, Gemcitabine, and Oxaliplatin
regimen
paclitaxel, gemcitabine, and oxaliplatin: 1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00183820-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0001
arm key
OG000
arm label
Paclitaxel, Gemcitabine, and Oxaliplatin
regimen
paclitaxel, gemcitabine, and oxaliplatin: 1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00183820-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT00183820
outcome key
om-0002
arm key
OG000
arm label
Paclitaxel, Gemcitabine, and Oxaliplatin
regimen
paclitaxel, gemcitabine, and oxaliplatin: 1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00183820-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT00183820
harm key
EG000
source section id
NCT00183820-ae
event group key
EG000
event group label
Paclitaxel, Gemcitabine, and Oxaliplatin
serious affected
29
serious at risk
30
other affected
29
other at risk
30
frequency threshold
0
collection period
about 9 years
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