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Brief Title: Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer
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)
Study ID: NCT01812486
Brief Summary: 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.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospitals UZLeuven, Leuven, , Belgium