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← Head and Neck Neoplasm

NCT01087970 · STUDY IN CONTEXT

A Study for Participants With Recurrent or Metastatic Squamous Cell 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.

exploratory · POSTED

Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.

All enrolled participants who received at least 1 dose of any study drug.

→

primary · POSTED

PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.

All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.

→

secondary · POSTED

OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.

All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.

→

secondary · POSTED

PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.

All treated participants excluding those from a noncompliant study site.

→

secondary · POSTED

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

→

secondary · POSTED

PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.

All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

→

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

EQ-5D · Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)

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
NCT01087970
qol key
qol-0003
source section id
NCT01087970-om-0003
source outcome index
3
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
time frame
Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
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
NCT01087970
trial label
A Study for Participants With Recurrent or Metastatic Squamous Cell 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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0005
    source section id
    NCT01087970-om-0005
    source outcome index
    5
    endpoint
    Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)
    endpoint definition
    Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.
    time origin
    From enrollment to 30 days post-treatment discontinuation up to 26.4 months
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All enrolled participants who received at least 1 dose of any study drug.
    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
    NCT01087970
    outcome key
    om-0000
    source section id
    NCT01087970-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
    time origin
    From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.
    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
    NCT01087970
    outcome key
    om-0001
    source section id
    NCT01087970-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.
    time origin
    From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.
    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
    NCT01087970
    outcome key
    om-0002
    source section id
    NCT01087970-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)
    endpoint definition
    PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
    time origin
    From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants excluding those from a noncompliant study site.
    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
    NCT01087970
    outcome key
    om-0003
    source section id
    NCT01087970-om-0003
    source outcome index
    3
    endpoint
    Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
    endpoint definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
    time origin
    Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
    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
    NCT01087970
    outcome key
    om-0004
    source section id
    NCT01087970-om-0004
    source outcome index
    4
    endpoint
    Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
    endpoint definition
    PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.
    time origin
    Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
    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
    NCT01087970
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    58
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    58
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    58
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
    regimen
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01087970-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    harm key
    EG000
    source section id
    NCT01087970-ae
    event group key
    EG000
    event group label
    Cetuximab + Pemetrexed + Carboplatin
    serious affected
    23
    serious at risk
    63
    other affected
    63
    other at risk
    63
    frequency threshold
    5
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    harm key
    EG001
    source section id
    NCT01087970-ae
    event group key
    EG001
    event group label
    Cetuximab + Pemetrexed + Cisplatin
    serious affected
    3
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01087970
    qol key
    qol-0003
    source section id
    NCT01087970-om-0003
    source outcome index
    3
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
    time frame
    Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
    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