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NCT Number: NCT06216171

Adaptive Radiotherapy in Head and Neck Tumor Patients

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.

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Key information

Conditions

Head and Neck Neoplasms Adaptive Radiotherapy Head and Neck Cancer Neoplasms Neoplasms by Site Optimization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ECOG 0/1 No prior cancer treatment

Exclusion criteria

ECOG 2-4 Prior cancer treatment

Treatment and study plan

Adaptive Radiotherapy

Radiation

Adaptive Radiotherapy

image guided radiotherapy without online adaptation

Radiation

image guided radiotherapy without online adaptation

Primary outcomes

  1. EORTC CTC AE Score

    Time frame: 2 months - 5 years

    quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017

  2. Dysphagia score

    Time frame: 2 months - 5 years

    Dysphagia score

Secondary outcomes

  1. Overall Survival

    Time frame: 2-5 years

    Overall Survival

  2. Progression Free Survival

    Time frame: 2-5 years

    Progression Free Survival

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)

Acronym: ProHEART

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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