EA3132

Clinical Trial Title Phase II Randomized Trial of Adjuvant Radiotherapy With or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Trial Status Open to Enrollment
Start Date 06/29/2018
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Head and Neck Carcinoma
Description This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.
Eligibility Criteria
  • Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA
  • Patient has undergone total resection of the primary tumor with curative intent
  • For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry
  • Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
  • Patients with recurrent disease or multiple primaries are ineligible

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02734537
Principal Investigator Jacqueline Vuky, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org