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← Penile Cancer

NCT00512096 · STUDY IN CONTEXT

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

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

Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.

Participants who completed chemotherapy without progression then had surgical resection.

→

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-penile-cancer
nct id
NCT00512096
trial label
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis
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
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT00512096
    outcome key
    om-0000
    source section id
    NCT00512096-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Pathologic Complete Remission (pCR)
    endpoint definition
    Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.
    time origin
    restaging with second and fourth 21-day cycles followed by surgery
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who completed chemotherapy without progression then had surgical resection.
    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-penile-cancer
    nct id
    NCT00512096
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cisplatin + Ifosfamide + Paclitaxel
    regimen
    Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00512096-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT00512096
    harm key
    EG000
    source section id
    NCT00512096-ae
    event group key
    EG000
    event group label
    Cisplatin + Ifosfamide + Paclitaxel
    serious affected
    3
    serious at risk
    30
    other affected
    13
    other at risk
    30
    frequency threshold
    2
    collection period
    Nine years and 6 months
    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