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← Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7

NCT02388932 · STUDY IN CONTEXT

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.

Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels.

→

primary · POSTED

Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0

Participants who enrolled in study and were treated.

→

secondary · POSTED

Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup

Patients who went on study

→

secondary · POSTED

Kaplan-Meier estimates will be used to plot local progression free survival.

No patients were alive at 12 months, so no analysis was done.

→

secondary · POSTED

Trend tests will be used to investigate the relationship between SBRT dose and response.

There was insufficient patient accrual to perform additional statistical analysis.

→

secondary · POSTED

Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0

Patients who were eligible for evaluation for SBRT-related morbidity incidence

→

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

Unnamed quality-of-life measure · Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT02388932
qol key
qol-0006
source section id
NCT02388932-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
measure definition
Repeated analysis of variance measures will be used to analyze the quality of life data.
time frame
Up to 12 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No patient was able to complete 3 month follow up to provide this QOL information
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT02388932
trial label
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0000
    source section id
    NCT02388932-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) of Head and Neck SBRT
    endpoint definition
    Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.
    time origin
    3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels.
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0001
    source section id
    NCT02388932-om-0001
    source outcome index
    1
    endpoint
    Incidence of Dose Limiting Toxicities (DLTs)
    endpoint definition
    Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
    time origin
    3 months from start of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who enrolled in study and were treated.
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0002
    source section id
    NCT02388932-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who went on study
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0003
    source section id
    NCT02388932-om-0003
    source outcome index
    3
    endpoint
    Local Progression Free Survival
    endpoint definition
    Kaplan-Meier estimates will be used to plot local progression free survival.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were alive at 12 months, so no analysis was done.
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0004
    source section id
    NCT02388932-om-0004
    source outcome index
    4
    endpoint
    Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
    endpoint definition
    Trend tests will be used to investigate the relationship between SBRT dose and response.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    There was insufficient patient accrual to perform additional statistical analysis.
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0005
    source section id
    NCT02388932-om-0005
    source outcome index
    5
    endpoint
    Incidence of SBRT Related Morbidity
    endpoint definition
    Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were eligible for evaluation for SBRT-related morbidity incidence
    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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (SBRT)
    regimen
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02388932-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    harm key
    EG000
    source section id
    NCT02388932-ae
    event group key
    EG000
    event group label
    Treatment (SBRT)
    serious affected
    0
    serious at risk
    3
    other affected
    1
    other at risk
    3
    frequency threshold
    0
    collection period
    Adverse events were collected from start of treatment to end of study (over a period of approximately 6 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
    nct id
    NCT02388932
    qol key
    qol-0006
    source section id
    NCT02388932-om-0006
    source outcome index
    6
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
    measure definition
    Repeated analysis of variance measures will be used to analyze the quality of life data.
    time frame
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    No patient was able to complete 3 month follow up to provide this QOL information
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice