NCT00423150 · STUDY IN CONTEXT

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

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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.

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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-esophageal-cancer
nct id: NCT00423150
trial label: Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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

release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer
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

release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer
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

release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer
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