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

Completed · Not applicable

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT00206752

Run by

Beth Israel Medical Center

People needed

45

Starts

2004-08-01

Expected to finish

2015-02-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion >1 cm from the midline.
• Patient has no clinical or radiologic evidence of contralateral neck node metastases.
• No evidence of distant metastasis.
• No previous history of radiation therapy or chemotherapy
• performance status 0-2
• Age >= 18
• Signed informed consent
• Patients must be accessible for treatment and follow-up

You may not qualify if…

• HIV positive patients
• Pregnancy or any patients not practicing contraception
• Active tobacco or alcohol addiction (as assessed by medical caregiver)
• Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
• Concomitant use of any trial anticancer therapeutic within 30 days of entry
• Uncontrolled hypertension
• Known hypersensitivity to mammalian cell-derived products

Where it is running

• Beth Israel Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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