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← recurrent Oropharyngeal Cancer

NCT01267240 · STUDY IN CONTEXT

Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

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

primary · POSTED

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Source null

→

secondary · POSTED

Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.

16 patients of the 25 were eligible for response assessment.

→

secondary · POSTED

PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.

16 of 25 patients were evaluable for response.

→

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-oropharyngeal-cancer-recurrent-f3bd66bf
nct id
NCT01267240
trial label
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0000
    source section id
    NCT01267240-om-0000
    source outcome index
    0
    endpoint
    Response Rate According to Response Evaluation Criteria in Solid Tumors
    endpoint definition
    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
    time origin
    Up to 1 year
    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-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0001
    source section id
    NCT01267240-om-0001
    source outcome index
    1
    endpoint
    Survival
    endpoint definition
    Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.
    time origin
    Up to 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    16 patients of the 25 were eligible for response assessment.
    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-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0002
    source section id
    NCT01267240-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival
    endpoint definition
    PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.
    time origin
    From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    16 of 25 patients were evaluable for response.
    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-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Capecitabine, Vorinostat)
    regimen
    Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01267240-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Capecitabine, Vorinostat)
    regimen
    Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01267240-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Capecitabine, Vorinostat)
    regimen
    Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01267240-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01267240
    harm key
    EG000
    source section id
    NCT01267240-ae
    event group key
    EG000
    event group label
    Arm I (Capecitabine, Vorinostat)
    serious affected
    7
    serious at risk
    25
    other affected
    25
    other at risk
    25
    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