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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Royal Marsden Hospital
London, United Kingdom
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
Time frame: 12 months after radiotherapy
Acute toxicity
Time frame: Up to 3 months after radiotheapy
Late toxicity
Time frame: Up to 60 months after radiotherapy
Local control
Time frame: Up to 60 months after radiotherapy
Loco-regional control
Time frame: Up to 60 months after radiotherapy
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Time frame: Up to 60 months after radiotherapy
Disease free survival
Time frame: Up to 60 months after radiotherapy
Overall Survival
Time frame: Up to 60 months after radiotherapy
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