Postoperative Radiation + chemotherapy for Head & Neck Cancer

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of The Head And Neck

  • Clinical Trial Information

    Trial Contact: Britton, David ; Simoni, Christine; Frankos, Marie; Caldwell, Chloe M

  • IRB No: RTOG 1216

    Protocol Abbrev: RTOG 1216

    Principal Investigator: Rafael R. Manon, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: RTOG 1216

    Treatment: Drug: cisplatin Drug: docetaxel Biological: cetuximab Radiation: intensity-modulated radiation therapy

    Therapies Involved: Chemotherapy ID: NCT01810913

  • Objective

    This trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with head and neck cancer.

  • Key Eligibility

    Must have histologically or cytologically proven diagnosis of head and neck squamous cell carcinoma involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx. Must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration. Must have at least 1 of the following high-risk pathologic features: extra capsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink). Must have pathologic stage III or IV HNSCC, including no distant metastases.