Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers Clinical Trial
Official title:
A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
This study is a phase I/II dose escalation trial designed to test the feasibility of
delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety
and possible improvement in outcome when the dose is increased.
This protocol is in fact two studies running in parallel: thyroid cancer patients and
larynx/ hypopharynx cancer patients. These two groups of patients are being treated
differently and will be analysed separately.
The primary objective of this Phase I sequential cohort study was to determine the
feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced
high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2
dose fractionation regimens.
DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions
DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily
fractions and elective nodal levels 54 Gy in 30 daily fractions
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment