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NCT00423150 · STUDY IN CONTEXT

Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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

Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

→

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-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT00423150
trial label
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced 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
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00423150
    outcome key
    om-0000
    source section id
    NCT00423150-om-0000
    source outcome index
    0
    endpoint
    Tumor Responses (Complete and Partial Response)
    endpoint definition
    Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
    time origin
    From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
    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-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00423150
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
    analyzed count
    82
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00423150-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00423150
    harm key
    EG000
    source section id
    NCT00423150-ae
    event group key
    EG000
    event group label
    Temozolomide
    serious affected
    37
    serious at risk
    86
    other affected
    83
    other at risk
    86
    frequency threshold
    5
    collection period
    Source null
    event definition
    Other adverse events: these non-serious events are treatment-emergent.
    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