Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase 2
Completed
- Conditions
- Head and Neck Neoplasm
- Interventions
- Registration Number
- NCT00623558
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Docetaxel Docetaxel+CDDP+Cetuximab 2 Cisplatin Docetaxel+CDDP+Cetuximab 1 Docetaxel Docetaxel+CDDP 1 Cisplatin Docetaxel+CDDP 2 Cetuximab Docetaxel+CDDP+Cetuximab
- Primary Outcome Measures
Name Time Method Response rate after induction treatment
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie cetuximab's efficacy in HNSCC when combined with docetaxel and cisplatin?
How does cetuximab plus docetaxel/cisplatin compare to standard induction chemotherapy for locally advanced HNSCC?
Which biomarkers correlate with response to cetuximab-based induction therapy in NCT00623558 HNSCC trial?
What are the key adverse events associated with cetuximab-docetaxel-cisplatin induction in HNSCC patients?
Are there alternative EGFR-targeted therapies being tested in combination with platinum-based chemotherapies for HNSCC?
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of