Intensity Modulated Radiation Therapy for Head and Neck Cancer

November 28, 2019 updated by: University Health Network, Toronto

A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer

Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.

The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.

Study Overview

Status

Completed

Conditions

Nasopharyngeal Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
less than 70 yrs of age
Stage T1-T4; N0-N3; M0
KPS less than 70
no prior RT to H&N or chemotherapy for H&N
no other malignancy except non-melanomatous skin cancer
no distant mets
no contraindication to RT or chemotherapy
adequate organ function
informed consent

Exclusion Criteria

Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques. Time Frame: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter	q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter

Secondary Outcome Measures

Outcome Measure
-the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
-the nature and prevalence of acute and late side effects and their relationship to local dose.
-the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
-evaluation of failure with respect to the doses in the region of the failure
-quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

Principal Investigator: Andrew Bayley, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria