Clinical Trial 18994

• Overview

  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..

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy

  Medications:

  Radiotherapy (); cisplatin ()

• Inclusion Criteria

  • PRE-REGISTRATION (STEP 0):
  • Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); clinical stage T2-T4a, N0-2, M0 or T1, N1-2, M0
  • Potential participant has undergone total resection of the primary tumor with curative intent
  • Must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
  • Must have the following assessments done within 80 days prior to randomization: 1.) Examination by an Ear, Nose, and Throat (ENT)/Head & Neck Surgeon; 2.) Neck computed tomography (CT) scan (from skull base to clavicle) and; 3.) Chest x-ray (or chest CT scan or CT/positron emission tomography [PET] of the chest) to rule out distant metastatic disease.
  • A paraffin-embedded surgical tumor tissue specimen has been located, is available for shipment to Foundation Medicine, Inc. following pre-registration
  • Potential participants with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer
  • Must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
  • RANDOMIZATION (STEP 1):
  • Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 7 weeks prior to randomization
  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
  • Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin => Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
  • Must not have an intercurrent illness likely to interfere with protocol therapy

• Exclusion Criteria

  • Do not meet Inclusion Criteria
  • PRE-REGISTRATION (STEP 0):
  • Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery are not eligible

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