Clinical trial NCT06216171: Adaptive Radiotherapy in Head and Neck Tumor Patients
Official title: Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Head and Neck Cancer
Adaptive Radiotherapy
Optimization
Keywords: Head and Neck Neoplasms
Head and Neck Cancer
Adaptive Radiotherapy
Optimization
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

ECOG 0/1 No prior cancer treatment

Exclusion Criteria:

ECOG 2-4 Prior cancer treatment

Primary outcomes:
measure: EORTC CTC AE Score
timeFrame: 2 months - 5 years
measure: Dysphagia score
timeFrame: 2 months - 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2-5 years
measure: Progression Free Survival
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Maja Guberina
Study officials:
References: