TriangleNCT00410826 · STUDY IN CONTEXT
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV 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
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Reported safety
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
- nct id
- NCT00410826
- trial label
- Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV 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
- 3
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0000
- source section id
- NCT00410826-om-0000
- source outcome index
- 0
- endpoint
- Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
- endpoint definition
- Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
- time origin
- 12 weeks after the completion of therapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0001
- source section id
- NCT00410826-om-0001
- source outcome index
- 1
- endpoint
- Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
- endpoint definition
- Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
- time origin
- 30 days after the completion of therapy
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0002
- source section id
- NCT00410826-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
- endpoint definition
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- time origin
- Every 3 months for up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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
- nct id
- NCT00410826
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Cisplatin and Radiotherapy)
- regimen
- Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00410826-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Radiotherapy, Erlotinib)
- regimen
- Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
- analyzed count
- 95
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00410826-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Cisplatin and Radiotherapy)
- regimen
- Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00410826-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma
- nct id
- NCT00410826
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Radiotherapy, Erlotinib)
- regimen
- Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
- analyzed count
- 99
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00410826-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma
- nct id
- NCT00410826
- harm key
- EG000
- source section id
- NCT00410826-ae
- event group key
- EG000
- event group label
- Arm A (Cisplatin and Radiotherapy)
- serious affected
- 32
- serious at risk
- 96
- other affected
- 87
- other at risk
- 96
- frequency threshold
- 5
- collection period
- Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy.
- event definition
- All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
- 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-squamous-cell-carcinoma
- nct id
- NCT00410826
- harm key
- EG001
- source section id
- NCT00410826-ae
- event group key
- EG001
- event group label
- Arm B (Cisplatin, Radiotherapy, Erlotinib)
- serious affected
- 38
- serious at risk
- 95
- other affected
- 91
- other at risk
- 95
- frequency threshold
- 5
- collection period
- Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy.
- event definition
- All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
- 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