Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

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

Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

The Principal Investigator left the institution. Despite exhausting all efforts to contact the Responsible Party and study team members to retrieve the collected data, or to have them enter the data, efforts were unsuccessful, and no data are available to be reported

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secondary · POSTED

Improvement in progression free survival (PFS)in locally advanced stage III and IV head and neck cancer patients with sequential (ICT) followed by Concurrent chemo-radiotherapy (CR) using monoclonal antibody Cetuximab as compared to historical controls.

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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-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id: NCT01326923
trial label: Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer
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: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01326923
outcome key
om-0000
source section id
NCT01326923-om-0000
source outcome index
0
endpoint
Complete Response
endpoint definition
Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
time origin
Analysis at Week 26
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The Principal Investigator left the institution. Despite exhausting all efforts to contact the Responsible Party and study team members to retrieve the collected data, or to have them enter the data, efforts were unsuccessful, and no data are available to be reported
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-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01326923
outcome key
om-0001
source section id
NCT01326923-om-0001
source outcome index
1
endpoint
Progression Free Survival
endpoint definition
Improvement in progression free survival (PFS)in locally advanced stage III and IV head and neck cancer patients with sequential (ICT) followed by Concurrent chemo-radiotherapy (CR) using monoclonal antibody Cetuximab as compared to historical controls.
time origin
Analysis at Week 26
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Principal Investigator left the institution. Despite exhausting all efforts to contact the Responsible Party and study team members to retrieve the collected data, or to have them enter the data, efforts were unsuccessful, and no data are available to be reported
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-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01326923
outcome key
om-0000
arm key
OG000
arm label
Single Arm
regimen
Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326923-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01326923
outcome key
om-0001
arm key
OG000
arm label
Single Arm
regimen
Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326923-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01326923
harm key
EG000
source section id
NCT01326923-ae
event group key
EG000
event group label
Single Arm
serious affected
2
serious at risk
7
other affected
0
other at risk
7
frequency threshold
0
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

setting source links

Preserved source evidence · Not medical advice