Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

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 stud

Trial Details

NCT ID
NCT02128906
Phase
PHASE2
Sponsor
Christopher Wilke
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Cisplatin
  • IMRT
  • Docetaxel
  • Cetuximab
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Pathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypo…
  • Patients must have stage III, IVa or IVb disease as determined by imaging studies and complete head and neck exam. Staging evaluation should be in …
  • Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomi…
  • Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor…

For full eligibility, visit ClinicalTrials.gov.

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