Status:

COMPLETED

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

Lead Sponsor:

Beth Israel Medical Center

Conditions:

Squamous Cell Carcinoma of the Head and Neck

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 th...

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 defi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2015

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00206752

Start Date

August 1 2004

End Date

February 1 2015

Last Update

March 30 2015

Active Locations (1)

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Beth Israel Medical Center

New York, New York, United States, 10003