NCT02055989

A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Conditions

• Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers
• Locally Advanced Thyroid Cancers

Interventions

Type	Name	Description
RADIATION	Dose-escalated radiotherapy level 1
RADIATION	Sequential dose-escalated radiotherapy level 2

Timeline

• Start date: 2002-01-01
• Primary completion: 2011-12-01
• First posted: 2014-02-05
• Last updated: 2014-02-05

Locations

1 site across 1 country: United Kingdom