A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy
Patients will be treated with definitive external beam radiation plus/minus chemotherapy
plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will
be treated with definitive radiation therapy, or definitive surgery plus post-operative
radiation therapy. Primary endpoints are loco-regional control, as well as quality of life,
xerostomia, mucositis, and neck fibrosis.
Salivary evaluations shall be performed prior to the initiation of radiation therapy, during
the second week of EBRT, and at the completion of radiation. Evaluations will also be
conducted at 3, 6, and 12 months after the completion of EBRT.
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT.
Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two
standardized mucositis scales will be used: the RTOG scale and the WHO scale.
Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done
at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
FACT (head and neck);Xerostomia related Quality of Life Questionnaire
Louis B Harrison, MD
Department of Radiation Oncology at Beth Israel Medical Center
United States: Food and Drug Administration
|Beth Israel Medical Center||New York, New York 10003|