Adaptive Radiotherapy in Head and Neck Tumor Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Adaptive Radiotherapy

    Radiation

    Adaptive Radiotherapy

  • image guided radiotherapy without online adaptation

    Radiation

    image guided radiotherapy without online adaptation

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Adaptive RadiotherapyExperimental treatment 1 intervention
Group B: Standard conventional Treatment Arm, IGRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

EORTC CTC AE Score

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

Time frame
2 months - 5 years
2

Dysphagia score

Dysphagia score

Time frame
2 months - 5 years

Secondary outcomes

1

Overall Survival

Overall Survival

Time frame
2-5 years
2

Progression Free Survival

Progression Free Survival

Time frame
2-5 years

Other outcomes

Sponsors and contacts

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