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← Adult Gliosarcoma

NCT00884741 · STUDY IN CONTEXT

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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.

exploratory · NOT_POSTED

Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)

Source null

→

exploratory · NOT_POSTED

Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)

Source null

→

primary · POSTED

Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.

All eligible randomized patients

→

primary · POSTED

Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.

All eligible randomized patients

→

secondary · POSTED

AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.

Eligible randomized patients with adverse event data who started study treatment.

→

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

EORTC QLQ · Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-adult-gliosarcoma
nct id
NCT00884741
qol key
qol-0003
source section id
NCT00884741-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
measure definition
Source null
time frame
Analysis can occur at or after time of primary outcome measure analysis.
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-adult-gliosarcoma
nct id
NCT00884741
trial label
Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
5
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0003
    source section id
    NCT00884741-om-0003
    source outcome index
    3
    endpoint
    Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
    endpoint definition
    Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
    time origin
    Analysis can occur at or after time of primary outcome measure analysis.
    analysis role
    exploratory
    reporting status
    NOT_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-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0004
    source section id
    NCT00884741-om-0004
    source outcome index
    4
    endpoint
    Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)
    endpoint definition
    Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)
    time origin
    Analysis can occur at or after time of primary outcome measure analysis.
    analysis role
    exploratory
    reporting status
    NOT_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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0000
    source section id
    NCT00884741-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
    time origin
    From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0001
    source section id
    NCT00884741-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
    time origin
    From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0002
    source section id
    NCT00884741-om-0002
    source outcome index
    2
    endpoint
    Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0
    endpoint definition
    AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.
    time origin
    Up to 30 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible randomized patients with adverse event data who started study treatment.
    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-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Randomized Arm 1: TMZ+RT + Placebo
    regimen
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    analyzed count
    309
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Randomized Arm 2: TMZ+RT + Bevacizumab
    regimen
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    analyzed count
    312
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Randomized Arm 1: TMZ+RT + Placebo
    regimen
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    analyzed count
    309
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Randomized Arm 2: TMZ+RT + Bevacizumab
    regimen
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    analyzed count
    312
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Randomized Arm 1: TMZ+RT + Placebo
    regimen
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    analyzed count
    300
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Randomized Arm 2: TMZ+RT + Bevacizumab
    regimen
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00884741-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    harm key
    EG000
    source section id
    NCT00884741-ae
    event group key
    EG000
    event group label
    Pre-Randomization TMZ+RT
    serious affected
    5
    serious at risk
    10
    other affected
    7
    other at risk
    10
    frequency threshold
    5
    collection period
    Source null
    event definition
    Data is reported for eligible randomized patients with adverse event data who started study treatment. Subjects experiencing more than one of a given serious adverse event (SAE) were counted only once for that SAE. The same methodology was applied for non-serious adverse events.
    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-adult-gliosarcoma
    nct id
    NCT00884741
    harm key
    EG001
    source section id
    NCT00884741-ae
    event group key
    EG001
    event group label
    Randomized Arm 1: TMZ+RT + Placebo
    serious affected
    115
    serious at risk
    300
    other affected
    292
    other at risk
    300
    frequency threshold
    5
    collection period
    Source null
    event definition
    Data is reported for eligible randomized patients with adverse event data who started study treatment. Subjects experiencing more than one of a given serious adverse event (SAE) were counted only once for that SAE. The same methodology was applied for non-serious adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    harm key
    EG002
    source section id
    NCT00884741-ae
    event group key
    EG002
    event group label
    Randomized Arm 2: TMZ+RT + Bevacizumab
    serious affected
    141
    serious at risk
    303
    other affected
    292
    other at risk
    303
    frequency threshold
    5
    collection period
    Source null
    event definition
    Data is reported for eligible randomized patients with adverse event data who started study treatment. Subjects experiencing more than one of a given serious adverse event (SAE) were counted only once for that SAE. The same methodology was applied for non-serious adverse events.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT00884741
    qol key
    qol-0003
    source section id
    NCT00884741-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
    measure definition
    Source null
    time frame
    Analysis can occur at or after time of primary outcome measure analysis.
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice