Clinical trial · Interventional
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00623558CI-TRIAL-00012875completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasm | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Docetaxel+CDDP
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- Docetaxel+CDDP+Cetuximab
- interventionNames
- Drug: Cetuximab
- Drug: Docetaxel
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- after induction treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC * ECOG performance status 0-1 * Age 18 or older than 18 years * Measurable disease by RECIST criteria * Having signed informed consent * ALT and AST\<2.5 times ULN * Serum albumin level ≥3.0g/dL * Serum AKP \< 2.5 times ULN * Bilirubin level \< 1.5mg/dL * Serum creatinine \<1.5 times ULN * WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl Exclusion Criteria: * Previous cytotoxic chemotherapy for HNSCC * Radiotherapy for targeted lesions within six months * Previous EGFR pathway-targeting therapy * Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry) * Distant metastatic disease * Heart failure, coronary artery disease, myocardial infarction within the last 6 months * Known allergy to any study treatment * Pregnancy or lactation period * Any investigational agent within the past 28 days * Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer * Legal incapacity
References
Publications (1)
- DERIVEDLee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24. PMID 26304911