NCT00084318 · STUDY IN CONTEXT

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma o

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

Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.

Eligible patients who started protocol treatment and did not withdraw consent.

→

secondary · POSTED

Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).

Eligible patients who started protocol treatment and did not withdraw consent

→

secondary · POSTED

Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.

Eligible patients who started protocol treatment and did not withdraw consent

→

secondary · POSTED

Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \>30%. \[RTOG = Radiation Therapy Oncology Group\]

Eligible patients who started protocol treatment and did not withdraw consent

→

secondary · POSTED

Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.

Eligible patients who started protocol treatment and did not withdraw consent

→

secondary · POSTED

Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).

Eligible patients who started protocol treatment and 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

No linked quality-of-life measure is recorded for this setting and study.

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: NCT00084318
trial label: Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma o
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: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0000
source section id
NCT00084318-om-0000
source outcome index
0
endpoint
Disease-free Survival
endpoint definition
Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.
time origin
From randomization to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0001
source section id
NCT00084318-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).
time origin
From randomization to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0002
source section id
NCT00084318-om-0002
source outcome index
2
endpoint
Treatment Tolerance
endpoint definition
Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.
time origin
From start of treatment to end of treatment (protocol treatment lasts seven weeks).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0003
source section id
NCT00084318-om-0003
source outcome index
3
endpoint
Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)
endpoint definition
Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \>30%. \[RTOG = Radiation Therapy Oncology Group\]
time origin
From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0004
source section id
NCT00084318-om-0004
source outcome index
4
endpoint
Frequency of Other Acute and Late Toxicity
endpoint definition
Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.
time origin
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0005
source section id
NCT00084318-om-0005
source outcome index
5
endpoint
Local-regional Control
endpoint definition
Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
time origin
From randomization to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started protocol treatment and did not withdraw consent.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0000
arm key
OG000
arm label
RT + Cisplatin + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0000
arm key
OG001
arm label
RT + Docetaxel + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0001
arm key
OG000
arm label
RT + Cisplatin + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0001
arm key
OG001
arm label
RT + Docetaxel + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0002
arm key
OG000
arm label
RT+Cisplatin+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0002
arm key
OG001
arm label
RT+Docetaxel+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0003
arm key
OG000
arm label
RT+Cisplatin+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0003
arm key
OG001
arm label
RT+Docetaxel+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0004
arm key
OG000
arm label
RT+Cisplatin+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0004
arm key
OG001
arm label
RT+Docetaxel+Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0005
arm key
OG000
arm label
RT + Cisplatin + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
outcome key
om-0005
arm key
OG001
arm label
RT + Docetaxel + Cetuximab
regimen
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
analyzed count
106
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00084318-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
harm key
EG000
source section id
NCT00084318-ae
event group key
EG000
event group label
RT+Cisplatin+Cetuximab
serious affected
42
serious at risk
97
other affected
97
other at risk
97
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-serious adverse events.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00084318
harm key
EG001
source section id
NCT00084318-ae
event group key
EG001
event group label
RT+Docetaxel+Cetuximab
serious affected
56
serious at risk
106
other affected
105
other at risk
106
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-serious adverse events.
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

setting source links

Preserved source evidence · Not medical advice