Adaptive Radiotherapy in Head and Neck Tumor Patients

Not Applicable

Recruiting

• Conditions: Optimization; Head and Neck Neoplasms; Head and Neck Cancer; Adaptive Radiotherapy
• Interventions: Radiation: Adaptive Radiotherapy; Radiation: image guided radiotherapy without online adaptation

• Registration Number: NCT06216171
• Lead Sponsor: University Hospital, Essen

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.

Study Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Study Start: 2024-01-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-06-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

ECOG 0/1 No prior cancer treatment

Exclusion Criteria

ECOG 2-4 Prior cancer treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adaptive Radiotherapy	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	image guided radiotherapy without online adaptation	Standard treatment option, image guided radiotherapy without online adaptation

Primary Outcome Measures

Name	Time	Method
EORTC CTC AE Score	2 months - 5 years	quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017
Dysphagia score	2 months - 5 years	Dysphagia score

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	2-5 years	Progression Free Survival
Overall Survival	2-5 years	Overall Survival

Trial Locations

Locations (1)

Maja Guberina; 🇩🇪 Essen, Germany