NCT00206752

Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2005-09-21
• Last updated: 2015-03-30

Locations

1 site across 1 country: United States