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← Head and Neck Neoplasm

NCT03067610 · STUDY IN CONTEXT

Involved Field Elective Volume De-Intensification Radiation Therapy for 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

The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.

Source null

→

secondary · POSTED

Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.

Source null

→

secondary · POSTED

Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.

Source null

→

secondary · POSTED

The prevalence of gastrostomy use up to 2 years will be described.

Source null

→

secondary · POSTED

The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).

Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR

→

secondary · POSTED

Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.

Reported the percentage of the total patient population who survived to 2 years post-treatment.

→

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

EORTC QLQ · Quality of Life (QOL) Patient Reported Outcomes (PRO)

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-head-and-neck-neoplasm
nct id
NCT03067610
qol key
qol-0001
source section id
NCT03067610-om-0001
source outcome index
1
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Quality of Life (QOL) Patient Reported Outcomes (PRO)
measure definition
Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
time frame
12 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Patient Utilities

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-head-and-neck-neoplasm
nct id
NCT03067610
qol key
qol-0004
source section id
NCT03067610-om-0004
source outcome index
4
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Patient Utilities
measure definition
The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
time frame
2 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR
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-head-and-neck-neoplasm
nct id
NCT03067610
trial label
Involved Field Elective Volume De-Intensification Radiation Therapy for 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
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0000
    source section id
    NCT03067610-om-0000
    source outcome index
    0
    endpoint
    Number of Patients With Solitary Elective Volume Recurrence
    endpoint definition
    The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
    time origin
    2 years
    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-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0001
    source section id
    NCT03067610-om-0001
    source outcome index
    1
    endpoint
    Quality of Life (QOL) Patient Reported Outcomes (PRO)
    endpoint definition
    Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
    time origin
    12 months
    analysis role
    secondary
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0002
    source section id
    NCT03067610-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
    endpoint definition
    Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.
    time origin
    2 years
    analysis role
    secondary
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0003
    source section id
    NCT03067610-om-0003
    source outcome index
    3
    endpoint
    Total Number of Participants With Gastrostomy Dependence
    endpoint definition
    The prevalence of gastrostomy use up to 2 years will be described.
    time origin
    2 years
    analysis role
    secondary
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0004
    source section id
    NCT03067610-om-0004
    source outcome index
    4
    endpoint
    Patient Utilities
    endpoint definition
    The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR
    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-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0005
    source section id
    NCT03067610-om-0005
    source outcome index
    5
    endpoint
    Overall Survival
    endpoint definition
    Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Reported the percentage of the total patient population who survived to 2 years post-treatment.
    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-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Radiation Therapy
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Total Cohort Baseline
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Total Cohort 3 Month
    regimen
    Total cohort
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Total Cohort 6 Month
    regimen
    Total cohort
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Total Cohort 12 Month
    regimen
    Total cohort
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0001#groups/OG003
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Radiation Therapy
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0002#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Radiation Therapy
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Radiation Therapy
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Radiation Therapy
    regimen
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03067610-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT03067610
    harm key
    EG000
    source section id
    NCT03067610-ae
    event group key
    EG000
    event group label
    Radiation Therapy
    serious affected
    35
    serious at risk
    72
    other affected
    65
    other at risk
    72
    frequency threshold
    0
    collection period
    30 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-head-and-neck-neoplasm
    nct id
    NCT03067610
    qol key
    qol-0001
    source section id
    NCT03067610-om-0001
    source outcome index
    1
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Quality of Life (QOL) Patient Reported Outcomes (PRO)
    measure definition
    Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
    time frame
    12 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    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-head-and-neck-neoplasm
    nct id
    NCT03067610
    qol key
    qol-0004
    source section id
    NCT03067610-om-0004
    source outcome index
    4
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Patient Utilities
    measure definition
    The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
    time frame
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR
    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