Head/Neck Cancer 0920

April 26, 2017

Sponsor: Radiation Therapy Oncology Group

Number: 0920

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) that studies radiation therapy alone to see how well it works compared with radiation therapy and Cetuximab. This study focuses on treating patients who have undergone surgery for head and neck cancer that has spread to nearby tissues or organs. Radiation therapy uses high-energy x-rays to kill tumor cells. Using a 3-dimensional (3-D) image of the tumor to help focus the radiation directly onto the tumor, and giving the radiation in higher doses over a shorter period of time, may kill more tumor cells and cause fewer side effects. Monoclonal antibodies, such as Cetuximab, may block tumor growth by targeting certain cells. It is not yet known whether radiation therapy is more effective when given alone or together with Cetuximab in treating patients with head and neck cancer that has been removed by surgery.

Who’s eligible:

  • Patients must have a pathologically (histologically- tissue microscopically examined) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS], etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excluded.
  • There must be a clinical stage T1, N1-2 or T2-4a, N0-2, M0 (N#-amount of lymph nodes involved M# whether he cancer has spread to other parts of the body) including no distant metastases, based upon the following minimum diagnostic workup:
    • General history and physical examination by a radiation oncologist and/or medical oncologist within 8 weeks prior to registration
    • Examination by an ear, nose and throat (ENT) or head & neck surgeon, within 8 weeks prior to registration; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is recommended but not required
    • Chest x-ray (at a minimum) or chest computed tomography (CT) scan (with or without contrast) or CT/positron emission tomography (PET) of chest (with or without contrast), within 8 weeks prior to registration
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, Backus Hospital, and Hartford Hospital.

Cancer Clinical Research Office