Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Completed · Not applicable

Conditions studied: Head and Neck Cancer

In brief

The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.

Key facts

Study ID

NCT00580983

Run by

University of Michigan Rogel Cancer Center

People needed

90

Starts

2003-08-01

Expected to finish

2010-06-01

Last updated by the study team

2016-09-07

Who can join

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

You may qualify if…

• All patients must have histologically confirmed invasive cancer of the head and neck.
• Irradiation to both neck sides is required.
• Standard radiation techniques would irradiate most of both parotid glands to a high dose (>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement.
• Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible.
• Karnofsky performance status >60
• Patients receiving or not receiving chemotherapy are eligible.
• All patients must sign an informed consent.
• Pre-treatment laboratory criteria:
• WBC (White Blood Cell) > 3500/ul, granulocyte > 1500/ul.
• Platelet count > 100,000/ul.
• Creatinine clearance > 60 cc/min. to receive cisplatin; creatinine clearance 30-59 cc/min to receive carboplatin.
• Bilirubin < 1.5 mg% with no evidence of obstructive liver disease.
• AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) equal to or less than 2.5 x upper limit of normal.

You may not qualify if…

• Patients who received past irradiation to the head and neck are not eligible.
• Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.
• Prior head and neck radiation or prior chemotherapy.
• Documented evidence of distant metastases.
• Active infection.
• Pregnancy or lactation; patients must use effective contraception during the course of the clinical trial.
• Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment.
• Patients residing in prison.
• Age < 18 years.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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