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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— Unilateral  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206752
• Other study ID #: 186-03
• Secondary ID: ETH136-03D
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 27, 2015
• Start date: August 2004
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Radiation:
• Radiation therapy
definitive external beam radiation in the ipsilateral neck.
• definitive external beam radiation in the ipsilateral neck
definitive external beam radiation in the ipsilateral neck

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACT (head and neck);Xerostomia related Quality of Life Questionnaire		September 2010	No