Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck
Unilateral
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
2 other identifiers
interventional
45
1 country
1
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 the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 30, 2015
March 1, 2015
10.5 years
September 13, 2005
March 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
FACT (head and neck);Xerostomia related Quality of Life Questionnaire
September 2010
Study Arms (1)
unilateral radiation therapy
EXPERIMENTALdefinitive external beam radiation in the ipsilateral neck.
Interventions
definitive external beam radiation in the ipsilateral neck.
definitive external beam radiation in the ipsilateral neck
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Medical Center
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Hu, MD
Department of Radiation Oncology at Beth Israel Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
August 1, 2004
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 30, 2015
Record last verified: 2015-03