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 November 2013 by Beth Israel Medical Center
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00206752
First received: September 13, 2005
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00206752

Contacts
Contact: Louis B Harrison, MD 212-844-8087 LHarrison@bethisraelny.org

Locations
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Robin Metcalfe-Klaw, BA    212-844-8285    rmetcalfe-klw@chpnet.org   
Sub-Investigator: Kenneth S Hu, MD         
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Louis B Harrison, MD Department of Radiation Oncology at Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00206752     History of Changes
Other Study ID Numbers: 186-03, ETH136-03D
Study First Received: September 13, 2005
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on August 19, 2014