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Spots Global Cancer Trial Database for Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer

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Trial Identification

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

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospitals UZLeuven, Leuven, , Belgium

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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