Adaptive Radiotherapy in Head and Neck Tumor Patients (ProHEART)

University Hospital Essen

Status: Enrolling

Conditions: Adaptive Radiotherapy; Optimization; Head and Neck Neoplasms; Head and Neck Cancer

Treatments: Radiation: Adaptive Radiotherapy; Radiation: image guided radiotherapy without online adaptation

Study type: Interventional

Funder types: Other

Identifiers

NCT06216171

23-11674-BO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

ECOG 0/1 No prior cancer treatment

Exclusion criteria

ECOG 2-4 Prior cancer treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Adaptive Radiotherapy

Experimental group

Description:

Adaptive Radiotherapy, online onboard adaptation of the dosis to actual anatomy of the day by a specialist of radiation oncology and a medical physicist

Treatment:

Radiation: Adaptive Radiotherapy

Standard conventional Treatment Arm, IGRT

Active Comparator group

Description:

Standard treatment option, image guided radiotherapy without online adaptation

Treatment:

Radiation: image guided radiotherapy without online adaptation