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NCT00599131 · STUDY IN CONTEXT

Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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 proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.

The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.

→

secondary · POSTED

To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.

The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.

→

secondary · POSTED

To evaluate the quality of life (QOL).

The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.

→

secondary · POSTED

To determine the overall survival rates compared to the overall survival rates of historical controls.

The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.

→

secondary · POSTED

To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.

The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.

→

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 · The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.

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-laryngeal-cancer-locally-advanced-33e41c9f
nct id
NCT00599131
qol key
qol-0002
source section id
NCT00599131-om-0002
source outcome index
2
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.
measure definition
To evaluate the quality of life (QOL).
time frame
24 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
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-laryngeal-cancer-locally-advanced-33e41c9f
nct id
NCT00599131
trial label
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
5
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0000
    source section id
    NCT00599131-om-0000
    source outcome index
    0
    endpoint
    Percentage of Patients Achieving Histologic Complete Response
    endpoint definition
    The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
    time origin
    3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0001
    source section id
    NCT00599131-om-0001
    source outcome index
    1
    endpoint
    The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.
    endpoint definition
    To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.
    time origin
    Day 23
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0002
    source section id
    NCT00599131-om-0002
    source outcome index
    2
    endpoint
    The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.
    endpoint definition
    To evaluate the quality of life (QOL).
    time origin
    24 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0003
    source section id
    NCT00599131-om-0003
    source outcome index
    3
    endpoint
    Overall Survival Time
    endpoint definition
    To determine the overall survival rates compared to the overall survival rates of historical controls.
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0004
    source section id
    NCT00599131-om-0004
    source outcome index
    4
    endpoint
    The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia
    endpoint definition
    To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.
    time origin
    3 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Chemotherapy/Radiation/Surgery
    regimen
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00599131-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Chemotherapy/Radiation/Surgery
    regimen
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00599131-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Chemotherapy/Radiation/Surgery
    regimen
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00599131-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Chemotherapy/Radiation/Surgery
    regimen
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00599131-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Chemotherapy/Radiation/Surgery
    regimen
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00599131-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    harm key
    EG000
    source section id
    NCT00599131-ae
    event group key
    EG000
    event group label
    Chemotherapy/Radiation/Surgery
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    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-laryngeal-cancer-locally-advanced-33e41c9f
    nct id
    NCT00599131
    qol key
    qol-0002
    source section id
    NCT00599131-om-0002
    source outcome index
    2
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.
    measure definition
    To evaluate the quality of life (QOL).
    time frame
    24 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
    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