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Protocol No. EA3132

Principal Investigator Witek, Matthew

Phase II

Age Group Adult

Scope National

Sponsor Type National

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)

Objective 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. This study will compare these two treatment approaches based on the genetic analysis of the tumor. The changes in a gene called TP53 will be specifically studied to see if it influences the response to radiation therapy alone or radiation therapy in combination with cisplatin chemotherapy.

Treatment
Group 1 will get the usual radiation dose of 60 Gray

Group 2 will get the usual radiation dose 60 Gray along with cisplatin. Cisplatin is infused over 1-2 hours once a week for 6 weeks

Description
Randomized study, with 2 groups

Group 1 will receive the usual treatment of radiation therapy

Group 2 will receive the usual treatment of radiation therapy along with cisplatin.

Key Eligibility
  • 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: T3-T4a, N0-3, M0 or T1-T2, N1-3, M0.
  • Patient has undergone total resection of the primary tumor with curative intent.
  • 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
  • No distant metastatic disease.
  • Women must not be pregnant or breast-feeding
  • Acceptable renal and hepatic function

  • Applicable Disease Sites Head and Neck

    Status Open

    Participating Institutions Swedish American Hospital, Rockford ; UW Hospital and Clinics