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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Beth Israel Medical Center
Information provided by (Responsible Party):
Beth Israel Medical Center Identifier:
First received: September 13, 2005
Last updated: September 25, 2014
Last verified: September 2014

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.

Condition Intervention
Squamous Cell Carcinoma of the Head and Neck
Radiation: Radiation therapy
Radiation: definitive external beam radiation in the ipsilateral neck

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • FACT (head and neck);Xerostomia related Quality of Life Questionnaire [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00206752

Contact: Kenneth Hu, MD 212-844-8090

United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Rotsen Rocha, BS    212-844-8133   
Principal Investigator: Kenneth S Hu, MD         
Sponsors and Collaborators
Beth Israel Medical Center
Principal Investigator: Kenneth Hu, MD Department of Radiation Oncology at Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center Identifier: NCT00206752     History of Changes
Other Study ID Numbers: 186-03, ETH136-03D
Study First Received: September 13, 2005
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell processed this record on March 26, 2015