Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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.