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← Malignant Head and Neck Neoplasm

NCT00281840 · STUDY IN CONTEXT

Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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. 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-malignant-head-and-neck-neoplasm
nct id
NCT00281840
trial label
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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.
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
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00281840
    outcome key
    om-0000
    source section id
    NCT00281840-om-0000
    source outcome index
    0
    endpoint
    Time to Progression
    endpoint definition
    The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.
    time origin
    5 yrs after treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received at least one treatment on study
    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-malignant-head-and-neck-neoplasm
    nct id
    NCT00281840
    outcome key
    om-0001
    source section id
    NCT00281840-om-0001
    source outcome index
    1
    endpoint
    Response Rate
    endpoint definition
    The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by 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
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with evaluable tumors at the end of the study
    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-malignant-head-and-neck-neoplasm
    nct id
    NCT00281840
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bevacizumab With Docetaxel and Radiation Therapy
    regimen
    Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00281840-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00281840
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Bevacizumab With Docetaxel and Radiation Therapy
    regimen
    bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity. docetaxel: docetaxel IV over 1 hour once a week for 8 weeks conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks
    analyzed count
    26
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00281840-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00281840
    harm key
    EG000
    source section id
    NCT00281840-ae
    event group key
    EG000
    event group label
    Bevacizumab With Docetaxel and Radiation Therapy
    serious affected
    12
    serious at risk
    30
    other affected
    30
    other at risk
    30
    frequency threshold
    5
    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