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← Testicular Germ Cell Tumor

NCT00104676 · STUDY IN CONTEXT

Combination Chemotherapy in Treating Patients With Stage II or Stage III 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. 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

Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.

The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).

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secondary · POSTED

To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.

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-testicular-germ-cell-tumor
nct id
NCT00104676
trial label
Combination Chemotherapy in Treating Patients With Stage II or Stage III 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.
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
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0000
    source section id
    NCT00104676-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival Rate After 1 Course of Treatment
    endpoint definition
    Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
    time origin
    3 years from randomization
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0001
    source section id
    NCT00104676-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.
    time origin
    3 years from randomization
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
    analyzed count
    98
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00104676-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II
    regimen
    Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00104676-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
    analyzed count
    98
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00104676-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II
    regimen
    Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00104676-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    harm key
    EG000
    source section id
    NCT00104676-ae
    event group key
    EG000
    event group label
    Arm I
    serious affected
    37
    serious at risk
    98
    other affected
    98
    other at risk
    98
    frequency threshold
    0
    collection period
    Source null
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-germ-cell-tumor
    nct id
    NCT00104676
    harm key
    EG001
    source section id
    NCT00104676-ae
    event group key
    EG001
    event group label
    Arm II
    serious affected
    58
    serious at risk
    105
    other affected
    105
    other at risk
    105
    frequency threshold
    0
    collection period
    Source null
    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