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
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.
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
Measuring Overall Survival
Reported safety
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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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-testicular-cancer
- 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
Triangle