TriangleNCT00970502 · STUDY IN CONTEXT
Erlotinib, Celecoxib and Reirradiation for Recurrent 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
Number of participants with acute and late toxicity
Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Patients with locoregional and/or distant progression
At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.
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-laryngeal-cancer
- nct id
- NCT00970502
- trial label
- Erlotinib, Celecoxib and Reirradiation for Recurrent 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0000
- source section id
- NCT00970502-om-0000
- source outcome index
- 0
- endpoint
- Toxicity
- endpoint definition
- Number of participants with acute and late toxicity
- time origin
- 30 DAYS
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Erlotinib and celecoxib were administered orally
- 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-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0001
- source section id
- NCT00970502-om-0001
- source outcome index
- 1
- endpoint
- Clinical Response
- endpoint definition
- Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- time origin
- 20 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0002
- source section id
- NCT00970502-om-0002
- source outcome index
- 2
- endpoint
- Locoregional Progression
- endpoint definition
- Patients with locoregional and/or distant progression
- time origin
- 20 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0003
- source section id
- NCT00970502-om-0003
- source outcome index
- 3
- endpoint
- Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
- endpoint definition
- At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.
- time origin
- 1 year
- 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-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Celecoxib 200mg
- regimen
- Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Celecoxib 400mg
- regimen
- Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Celecoxib 600mg
- regimen
- Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Erlotinib + Celecoxib
- regimen
- erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Erlotinib + Celecoxib
- regimen
- erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Erlotinib + Celecoxib
- regimen
- Recommended dose of celecoxib was 400mg
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00970502-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-laryngeal-cancer
- nct id
- NCT00970502
- harm key
- EG000
- source section id
- NCT00970502-ae
- event group key
- EG000
- event group label
- Erlotinib + Celecoxib
- serious affected
- 14
- serious at risk
- 14
- other affected
- 14
- other at risk
- 14
- 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