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← Malignant Head and Neck Neoplasm

NCT00258310 · STUDY IN CONTEXT

Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo

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.

primary · POSTED

Compliance is defined as taking at least 80% of the prescribed dose for one year.

Source null

→

secondary · POSTED

Time to recurrence or death

All enrolled participants

→

secondary · POSTED

Estimated time from study entry to death from any cause

Entire study population

→

secondary · POSTED

Incidence of Second Primary Tumors

Entire study population

→

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
NCT00258310
trial label
Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
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
4
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
    NCT00258310
    outcome key
    om-0000
    source section id
    NCT00258310-om-0000
    source outcome index
    0
    endpoint
    Compliance With Treatment .
    endpoint definition
    Compliance is defined as taking at least 80% of the prescribed dose for one year.
    time origin
    within 365 days
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0001
    source section id
    NCT00258310-om-0001
    source outcome index
    1
    endpoint
    Recurrence-free Survival
    endpoint definition
    Time to recurrence or death
    time origin
    Within 3 years of end of study.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All enrolled participants
    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-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0002
    source section id
    NCT00258310-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Estimated time from study entry to death from any cause
    time origin
    Within 3 years of end of study
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Entire study population
    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-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0003
    source section id
    NCT00258310-om-0003
    source outcome index
    3
    endpoint
    Incidence of Second Primary Tumors
    endpoint definition
    Incidence of Second Primary Tumors
    time origin
    Within 3 years of end of study
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Entire study population
    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
    NCT00258310
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00258310-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00258310-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00258310-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00258310-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00258310
    harm key
    EG000
    source section id
    NCT00258310-ae
    event group key
    EG000
    event group label
    Capcitabine
    serious affected
    2
    serious at risk
    35
    other affected
    3
    other at risk
    35
    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