OncoMatch/Clinical Trials/NCT02128906
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Is NCT02128906 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cisplatin and Docetaxel for squamous cell carcinoma.
Treatment: Cisplatin · Docetaxel · Cetuximab — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: ERCC1 expression
Diagnostic primary tumor tissue must be available for ERCC1 staining
Allowed: CDKN2A p16 overexpression
Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomization. Assessment of p16 status may occur locally or centrally. Note: The definition of p16(+) disease is diffuse nuclear and cytoplasmic staining in ≥ 70% of tumor cells.
Disease stage
Required: Stage III, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
Cannot have received: biologic/molecular targeted therapy
No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
Cannot have received: radiation therapy
No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
Cannot have received: radiation therapy above the clavicles
Patients must be untreated with radiation above the clavicles.
Cannot have received: anti-neoplastic investigational agents
Patients may not be receiving any other anti-neoplastic investigational agents.
Lab requirements
Blood counts
ANC > 1500/mm3; Hemoglobin > 8.0 g/dL; Platelet count > 100,000/mm3
Kidney function
Creatinine clearance ≥ 45 ml/min determined by 24-hour collection or estimated by the Cockraft-Gault formula
Liver function
Serum bilirubin < 2 mg/dL; AST and ALT < 3 times upper limit of normal (ULN)
Cardiac function
No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months.
Patients must have the following laboratory values measured within 14 days of registration: ANC > 1500/mm3; Hemoglobin > 8.0 g/dL; Platelet count > 100,000/mm3; Creatinine clearance ≥ 45 ml/min; Serum bilirubin < 2 mg/dL; AST and ALT < 3 times ULN. No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center - Radiation Oncology · Pittsburgh, Pennsylvania
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