Clinical Trial 18994

Study Title

Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing

Summary

This is a study to evaluate treatment after surgery for head and neck cancer. The purpose of this study is to compare two treatment approaches that are currently used after surgery for head and neck cancer. One approach is to administer radiation therapy alone. A second approach is to administer radiation therapy along with the chemotherapy drug, cisplatin. Cisplatin is approved by the United States Food and Drug Administration (FDA) to be used with radiation therapy for the treatment of head and neck cancer.

Objective

Primary Objective: 1. To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. Secondary Objective(s): 1. To evaluate the DFS of patients with stage III-IV SCCHN and nondisruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. 2. To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. 3. To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. 4. To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin. 5. To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach..