Clinical Trial

Adaptive Radiotherapy in Head and Neck Tumor Patients

Study acronym: ProHEART
Recruiting
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Record status
This record was last updated September 27, 2024 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-01-19; most recent amendment 2024-09-25.
Status change: Not Yet Recruiting → Recruiting 2024-02-07
Trial Details
NCT Number NCT06216171
Lead Sponsor University Hospital, Essen
Conditions Head and Neck Neoplasms, Head and Neck Cancer, Adaptive Radiotherapy, Optimization
Enrollment 30 participants
Start Date 2024-01-25
Primary Completion 2025-04-30 (estimated)
Study Completion 2028-01-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-27