NCT00313729 · STUDY IN CONTEXT

Temozolomide in Treating Patients With Low-Grade Glioma

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

Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.

Source null

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secondary · POSTED

Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.

Source null

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secondary · POSTED

Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0

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-central-nervous-system-tumors
nct id: NCT00313729
trial label: Temozolomide in Treating Patients With Low-Grade Glioma
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0000
source section id
NCT00313729-om-0000
source outcome index
0
endpoint
Response Rate (Complete and Partial Response)
endpoint definition
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
time origin
12 months
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
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0001
source section id
NCT00313729-om-0001
source outcome index
1
endpoint
Time to Tumor Progression
endpoint definition
Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
time origin
time from registration until date of the first documented progression, an average of 1 year
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
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0002
source section id
NCT00313729-om-0002
source outcome index
2
endpoint
Safety Profile
endpoint definition
Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
time origin
Time from registration up to 13 months
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

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0000
arm key
OG000
arm label
Temozolomide
regimen
Temozolomide temozolomide: Chemotherapy
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00313729-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0001
arm key
OG000
arm label
Temozolomide
regimen
Temozolomide temozolomide: Chemotherapy
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00313729-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
outcome key
om-0002
arm key
OG000
arm label
Temozolomide
regimen
Temozolomide temozolomide: Chemotherapy
analyzed count
120
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00313729-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00313729
harm key
EG000
source section id
NCT00313729-ae
event group key
EG000
event group label
Temozolomide
serious affected
17
serious at risk
120
other affected
31
other at risk
120
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