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← Malignant Head and Neck Neoplasm

NCT00047008 · STUDY IN CONTEXT

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With 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. 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

Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Eligible patients who did not withdraw consent.

→

secondary · POSTED

Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Eligible patients who did not withdraw consent

→

secondary · POSTED

Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Eligible patients who did not withdraw consent

→

secondary · POSTED

Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Eligible patients who did not withdraw consent

→

secondary · POSTED

Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Eligible patients who did not withdraw consent

→

secondary · POSTED

Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.

Eligible patients who did not withdraw consent

→

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 · Percentage of Participants With Toxicity Grade 3 or Higher

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-malignant-head-and-neck-neoplasm
nct id
NCT00047008
qol key
qol-0005
source section id
NCT00047008-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants With Toxicity Grade 3 or Higher
measure definition
Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
time frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible patients who did not withdraw consent
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00047008
qol key
qol-0009
source section id
NCT00047008-om-0009
source outcome index
9
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
measure definition
The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).
time frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores indicate better
population note
Eligible participants who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and one year.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes

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-malignant-head-and-neck-neoplasm
nct id
NCT00047008
qol key
qol-0010
source section id
NCT00047008-om-0010
source outcome index
10
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes
measure definition
Source null
time frame
From randomization to date of death or last follow-up
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No assays were performed and no data were collected for this outcome measure.
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-malignant-head-and-neck-neoplasm
nct id
NCT00047008
trial label
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With 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.
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
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0000
    source section id
    NCT00047008-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (Percentage of Participants Alive)
    endpoint definition
    Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent.
    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
    NCT00047008
    outcome key
    om-0001
    source section id
    NCT00047008-om-0001
    source outcome index
    1
    endpoint
    Local-regional Failure (Percentage of Participants With Local-regional Failure)
    endpoint definition
    Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    outcome key
    om-0002
    source section id
    NCT00047008-om-0002
    source outcome index
    2
    endpoint
    Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
    endpoint definition
    Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    outcome key
    om-0003
    source section id
    NCT00047008-om-0003
    source outcome index
    3
    endpoint
    Disease-free Survival (Percentage of Participants Alive Without Disease)
    endpoint definition
    Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    outcome key
    om-0004
    source section id
    NCT00047008-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
    endpoint definition
    Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    outcome key
    om-0005
    source section id
    NCT00047008-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Toxicity Grade 3 or Higher
    endpoint definition
    Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
    time origin
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Standard Fractionation RT + Cisplatin
    regimen
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    361
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Accelerated Fractionation RT + Cisplatin
    regimen
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    analyzed count
    360
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00047008-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    harm key
    EG000
    source section id
    NCT00047008-ae
    event group key
    EG000
    event group label
    Standard Fractionation RT + Cisplatin
    serious affected
    293
    serious at risk
    361
    other affected
    360
    other at risk
    361
    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 non-SAE 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    harm key
    EG001
    source section id
    NCT00047008-ae
    event group key
    EG001
    event group label
    Accelerated Fractionation RT + Cisplatin
    serious affected
    279
    serious at risk
    360
    other affected
    356
    other at risk
    360
    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 non-SAE 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00047008
    qol key
    qol-0005
    source section id
    NCT00047008-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants With Toxicity Grade 3 or Higher
    measure definition
    Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
    time frame
    From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible patients who did not withdraw consent
    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
    NCT00047008
    qol key
    qol-0009
    source section id
    NCT00047008-om-0009
    source outcome index
    9
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
    measure definition
    The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).
    time frame
    Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores indicate better
    population note
    Eligible participants who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and one year.
    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
    NCT00047008
    qol key
    qol-0010
    source section id
    NCT00047008-om-0010
    source outcome index
    10
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes
    measure definition
    Source null
    time frame
    From randomization to date of death or last follow-up
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    No assays were performed and no data were collected for this outcome measure.
    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