Head and Neck Cancer Clinical Trial
Official title:
Dose De-escalation to the Elective Nodal Sites, the Swallowing Apparatus and Neck Soft Tissues for Head and Neck Cancer: Multi-centre, Randomized Phase III Trial Using Image-guided Intensity-modulated Radiotherapy (IG-IMRT)
A randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a reduction of acute and late side effects without compromising tumor control.
1. Study hypothesis
Dose de-escalation in the elective nodal sites and off-target regions of the swallowing
apparatus delivered by IMRT does reduce overall rate of late dysphagia and neck
fibrosis comparing to the standard dose to the elective nodal sites.
2. Primary endpoint
To estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year
after the end of radiotherapy in patients receiving dose de-escalation to the elective
nodal sites and off-target regions of the swallowing apparatus applying IMRT.
3. Secondary endpoints
Local, regional and distant control Recurrence and site of recurrence Overall, disease-free
and disease-specific survival Acute toxicity Quality of life
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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