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)
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
overall rate of late dysphagia and neck fibrosis
Belgium: Federal Agency for Drugs and Medicinal Devices