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NCT00936936 · STUDY IN CONTEXT

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.

Source null

→

secondary · POSTED

Number of Participants alive and disease free 1 year post treatment completion.

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-testicular-cancer-recurrent-703d57c3
nct id
NCT00936936
trial label
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0000
    source section id
    NCT00936936-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With 2-year Event-Free Survival (EFS)
    endpoint definition
    Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
    time origin
    2 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0001
    source section id
    NCT00936936-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Number of Participants alive and disease free 1 year post treatment completion.
    time origin
    1 year post treatment
    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-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
    regimen
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00936936-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
    regimen
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00936936-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
    regimen
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00936936-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
    regimen
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00936936-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    harm key
    EG000
    source section id
    NCT00936936-ae
    event group key
    EG000
    event group label
    Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
    serious affected
    7
    serious at risk
    41
    other affected
    41
    other at risk
    41
    frequency threshold
    0
    collection period
    2 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-recurrent-703d57c3
    nct id
    NCT00936936
    harm key
    EG001
    source section id
    NCT00936936-ae
    event group key
    EG001
    event group label
    Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
    serious affected
    2
    serious at risk
    23
    other affected
    23
    other at risk
    23
    frequency threshold
    0
    collection period
    2 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