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← Malignant Head and Neck Neoplasm

NCT00057785 · STUDY IN CONTEXT

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal 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 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.

primary · POSTED

Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.

First 57 eligible patients who started study treatment.

→

secondary · NOT_POSTED

Rate of Xerostomia at 1 Year (Grade ≥ 2)

Source null

→

secondary · NOT_POSTED

Rate of Locoregional Control at 2 Years

Source null

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secondary · NOT_POSTED

Whole Mouth Saliva Output Relative to Pretreatment Measurements

Source null

→

secondary · NOT_POSTED

Other Acute and Late Toxicities

Source null

→

secondary · NOT_POSTED

Chemotherapy Compliance

Source null

→

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
NCT00057785
trial label
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal 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
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
6
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
    NCT00057785
    outcome key
    om-0000
    source section id
    NCT00057785-om-0000
    source outcome index
    0
    endpoint
    Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
    endpoint definition
    Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.
    time origin
    From start of treatment to end of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    First 57 eligible patients who started study treatment.
    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
    NCT00057785
    outcome key
    om-0001
    source section id
    NCT00057785-om-0001
    source outcome index
    1
    endpoint
    Rate of Xerostomia at 1 Year (Grade ≥ 2)
    endpoint definition
    Rate of Xerostomia at 1 Year (Grade ≥ 2)
    time origin
    From start of treatment to 1 year
    analysis role
    secondary
    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-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    outcome key
    om-0002
    source section id
    NCT00057785-om-0002
    source outcome index
    2
    endpoint
    Rate of Locoregional Control at 2 Years
    endpoint definition
    Rate of Locoregional Control at 2 Years
    time origin
    From registration to 2 years
    analysis role
    secondary
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    outcome key
    om-0003
    source section id
    NCT00057785-om-0003
    source outcome index
    3
    endpoint
    Whole Mouth Saliva Output Relative to Pretreatment Measurements
    endpoint definition
    Whole Mouth Saliva Output Relative to Pretreatment Measurements
    time origin
    From start of treatment to 1 year
    analysis role
    secondary
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    outcome key
    om-0004
    source section id
    NCT00057785-om-0004
    source outcome index
    4
    endpoint
    Other Acute and Late Toxicities
    endpoint definition
    Other Acute and Late Toxicities
    time origin
    From start of treatment to last follow-up
    analysis role
    secondary
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    outcome key
    om-0005
    source section id
    NCT00057785-om-0005
    source outcome index
    5
    endpoint
    Chemotherapy Compliance
    endpoint definition
    Chemotherapy Compliance
    time origin
    From start of treatment to end of treatment
    analysis role
    secondary
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    outcome key
    om-0000
    arm key
    OG000
    arm label
    IMRT +/- Chemotherapy
    regimen
    Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00057785-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00057785
    harm key
    EG000
    source section id
    NCT00057785-ae
    event group key
    EG000
    event group label
    IMRT +/- Chemotherapy
    serious affected
    55
    serious at risk
    68
    other affected
    68
    other at risk
    68
    frequency threshold
    5
    collection period
    Source null
    event definition
    Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
    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