Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)
| Registry | NCT06216171, acronym ProHEART |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | University Hospital, Essen (Other) |
| Conditions | Head and Neck Neoplasms, Head and Neck Cancer, Adaptive Radiotherapy, Optimization |
| Interventions | Adaptive Radiotherapy, image guided radiotherapy without online adaptation (Radiation) |
| Dates | start 2024-01-25, primary completion 2025-04-30, completion 2026-09-18, first posted 2024-01-22, last updated 2026-10-20 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Head and Neck Neoplasms All trials for Head and Neck Cancer All trials of Adaptive Radiotherapy All trials of image guided radiotherapy without online adaptation
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.
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.
Thus, in this trial we analyze ART in head and neck cancer in a prospective randomized trial.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Adaptive Radiotherapy | Experimental | Radiation: Adaptive Radiotherapy | Adaptive Radiotherapy, online onboard adaptation of the dosis to actual anatomy of the day by a specialist of radiation oncology and a medical physicist |
| Standard conventional Treatment Arm, IGRT | Active comparator | Radiation: image guided radiotherapy without online adaptation | Standard treatment option, image guided radiotherapy without online adaptation |
Sex: All, ages: 18 Years to any
Inclusion Criteria: ECOG 0/1 No prior cancer treatment Exclusion Criteria: ECOG 2-4 Prior cancer treatment
| Facility | City | Country | Status |
|---|---|---|---|
| Maja Guberina | Essen | Germany |