Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck
The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. We aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.
Squamous Cell Carcinoma of the Head and Neck
Radiation: Radiation therapy
Radiation: definitive external beam radiation in the ipsilateral neck
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- FACT (head and neck);Xerostomia related Quality of Life Questionnaire [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||February 2023|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Experimental: unilateral radiation therapy
definitive external beam radiation in the ipsilateral neck.
Radiation: Radiation therapy
definitive external beam radiation in the ipsilateral neck.Radiation: definitive external beam radiation in the ipsilateral neck
definitive external beam radiation in the ipsilateral neck
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206752
|Contact: Louis B Harrison, MD||212-844-8087||LHarrison@bethisraelny.org|
|United States, New York|
|Beth Israel Medical Center||Recruiting|
|New York, New York, United States, 10003|
|Contact: Robin Metcalfe-Klaw, BA 212-844-8285 firstname.lastname@example.org|
|Sub-Investigator: Kenneth S Hu, MD|
|Principal Investigator:||Louis B Harrison, MD||Department of Radiation Oncology at Beth Israel Medical Center|