Helical Tomotherapy Intensity Modulated Radiotherapy:A Phase I/II Pilot Study to Determine the Toxicity Profile, Pattern of Failures and Quality of Life of Patients With Squamous Cell Carcinoma of the Head and Neck
The mechanisms of action to explain the radiation-induced toxic effects resulting from the
more aggressive radiation therapy treatments of head and neck cancer include the additive
and synergistic increase in mucositis from the combination of chemotherapy and radiotherapy.
The severe toxicity associated with more aggressive radiation therapy treatments for
locoregional head and neck cancer limits the extent to which these treatments can be offered
since many patients present with nutritional deficiencies and consequent general debility.
Intensity Modulated Radiotherapy (IMRT) is a technology has the potential for exquisite dose
painting and structuring in such a manner that it can permit exclusion of normal tissues and
sensitive structures from the high dose radiation volume without compromising primary tumor
or nodal target coverage. In this phase I/II feasibility trial, radical radiotherapy will be
delivered using Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) to a dose of
66-70 Gy to involved areas and to at least 50 Gy to un-involved sites, treated
prophylactically. It is hypothesized that the pattern of failure and toxicity profiles of
patients treated with helical tomotherapy will demonstrate the greater efficacy of helical
tomotherapy, as compared with conventional radiotherapy, in the treatment of cancers of the
head and neck.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1) To determine the toxicity profile of patients with head and neck cancer treated with helical tomotherapy-IMRT
Samy El-Sayed, MD
Canada: Health Canada