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NCT00492089 · STUDY IN CONTEXT

Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer

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

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-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
nct id
NCT00492089
trial label
Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
    nct id
    NCT00492089
    outcome key
    om-0000
    source section id
    NCT00492089-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
    endpoint definition
    Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.
    time origin
    Baseline to 12 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.
    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-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
    nct id
    NCT00492089
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A: Bevacizumab
    regimen
    Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00492089-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
    nct id
    NCT00492089
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Crossover Arm B: Placebo Then Bevacizumab
    regimen
    Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00492089-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
    nct id
    NCT00492089
    harm key
    EG000
    source section id
    NCT00492089-ae
    event group key
    EG000
    event group label
    Bevacizumab
    serious affected
    4
    serious at risk
    11
    other affected
    5
    other at risk
    11
    frequency threshold
    5
    collection period
    2 years and 9 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-f8c4d324
    nct id
    NCT00492089
    harm key
    EG001
    source section id
    NCT00492089-ae
    event group key
    EG001
    event group label
    Placebo
    serious affected
    0
    serious at risk
    6
    other affected
    0
    other at risk
    6
    frequency threshold
    5
    collection period
    2 years and 9 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