TriangleNCT02177838 · STUDY IN CONTEXT
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck 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
Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference. Therefore, we have decided to provide summary statistics of primary and secondary outcomes. Among 3 cetuximab responders, two did not have progression within 2 year follow-up time and one had a locoregional recurrence and expired.
Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).
Among 4 cetuximab non-responders, none had locoregional failure at 2 years. Two patients had known HPV status; one patient was HPV+ and another patient HPV-. HPV status for the other two was unknown. HPV positive patient had no sign of progression within 2 years of follow-up. HPV negative patient had no sign of progression for 210 days until the last follow-up. One HPV unknown patient did not show progression within 2 years of follow-up, and the other HPV unknown patient had no progression for 115 days until the last follow-up.
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-docivyx-1bcd0a29
- nct id
- NCT02177838
- trial label
- Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0000
- source section id
- NCT02177838-om-0000
- source outcome index
- 0
- endpoint
- Locoregional Control in Cetuximab Responders
- endpoint definition
- Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference. Therefore, we have decided to provide summary statistics of primary and secondary outcomes. Among 3 cetuximab responders, two did not have progression within 2 year follow-up time and one had a locoregional recurrence and expired.
- time origin
- 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference.
- 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-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0001
- source section id
- NCT02177838-om-0001
- source outcome index
- 1
- endpoint
- Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria
- endpoint definition
- Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).
- time origin
- Day 14-21 after the first dose of cetuximab
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This measure what not evaluated because the study was halted prematurely due to low accrual.
- 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-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0002
- source section id
- NCT02177838-om-0002
- source outcome index
- 2
- endpoint
- Locoregional Control for Non-responders to Neoadjuvant Cetuximab
- endpoint definition
- Among 4 cetuximab non-responders, none had locoregional failure at 2 years. Two patients had known HPV status; one patient was HPV+ and another patient HPV-. HPV status for the other two was unknown. HPV positive patient had no sign of progression within 2 years of follow-up. HPV negative patient had no sign of progression for 210 days until the last follow-up. One HPV unknown patient did not show progression within 2 years of follow-up, and the other HPV unknown patient had no progression for 115 days until the last follow-up.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This measure what not evaluated because the study was halted prematurely due to low accrual.
- 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-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Cetuximab, Cisplatin, EBRT)
- regimen
- Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02177838-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Cetuximab, Cisplatin, EBRT)
- regimen
- Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02177838-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02177838
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Cetuximab, Cisplatin, EBRT)
- regimen
- Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02177838-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02177838
- harm key
- EG000
- source section id
- NCT02177838-ae
- event group key
- EG000
- event group label
- Treatment (Cetuximab, Cisplatin, EBRT)
- serious affected
- 1
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
- 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