Actively Recruiting
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Led by Christopher Wilke · Updated on 2026-04-16
120
Participants Needed
1
Research Sites
938 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied. This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 \[4F9\] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 \[4F9\] is expressed in a tumor.
CONDITIONS
Official Title
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell, undifferentiated, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx without distant metastasis
- Stage III, IVa, or IVb disease based on imaging and head and neck exam using AJCC 7th edition
- Known p16 status for oropharyngeal squamous cell carcinoma patients
- No prior curative-intent surgery for current diagnosis; diagnostic biopsy or simple tonsillectomy permitted
- More than 2 years since first HNSCC diagnosis if second primary tumor; no recurrence
- No simultaneous primaries or bilateral tumors except bilateral tonsil cancers or certain thyroid carcinomas
- No prior systemic chemotherapy, biologic/molecular targeted therapy, or radiation for head and neck cancer
- At least 2 years since chemotherapy or radiation for previous non-HNSCC malignancy
- No prior radiation above the clavicles
- Disease-free for at least 2 years after curatively-treated non-HNSCC malignancy, except specific exceptions
- Diagnostic primary tumor tissue available for ERCC1 staining
- ECOG Performance Status 0-1
- Age 18 years or older
- Measurable disease per RECIST 1.1
- Required lab values within 14 days before registration: ANC > 1500/mm3, Hb > 8.0 g/dL, PLT > 100,000/mm3
- Creatinine clearance ≥ 45 ml/min
- Serum bilirubin < 2 mg/dL
- AST and ALT < 3 times upper limit of normal
- Normal metabolic values for Na, K, Cl, glucose, Ca, Mg, albumin within specified ranges
- No prior severe infusion reaction to a monoclonal antibody
- Ability to understand and sign informed consent, including tissue submission for ERCC1 and p16 staining
- No recent unstable angina or myocardial infarction, no symptomatic congestive heart failure or serious cardiac arrhythmia
- No cerebrovascular ischemia or stroke within past 6 months
- No uncontrolled intercurrent illness including active infection or psychiatric illness
- Women not pregnant or breastfeeding
- Agreement to use adequate contraception during study participation
- HIV-positive patients on combination anti-retroviral therapy excluded
- Not receiving other anti-neoplastic investigational agents
You will not qualify if you...
- Evidence of distant metastasis
- Simultaneous primary tumors or bilateral tumors except certain exceptions
- Prior systemic chemotherapy, biologic/molecular targeted therapy, or radiation treatment for head and neck cancer
- Prior radiation above the clavicles
- Unstable angina or myocardial infarction within 6 months
- Symptomatic congestive heart failure or serious cardiac arrhythmia requiring medication
- Cerebrovascular ischemia or stroke within past 6 months
- Uncontrolled active infection, diabetes, hypertension, or psychiatric illness
- Pregnancy or breastfeeding
- Prior severe infusion reaction to monoclonal antibody
- HIV-positive patients on combination anti-retroviral therapy
- Receiving other anti-neoplastic investigational agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center - Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
S
Samantha Demko, RN
CONTACT
B
Brieana Marino, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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