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Adaptive Radiotherapy in Head and Neck Tumor Patients

NCT ID: NCT06216171

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2028-01-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Head and Neck Neoplasms Head and Neck Cancer Adaptive Radiotherapy Optimization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Adaptive Radiotherapy

Intervention Type RADIATION

Adaptive Radiotherapy

Standard conventional Treatment Arm, IGRT

Standard treatment option, image guided radiotherapy without online adaptation

Group Type ACTIVE_COMPARATOR

image guided radiotherapy without online adaptation

Intervention Type RADIATION

image guided radiotherapy without online adaptation

Interventions

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Adaptive Radiotherapy

Adaptive Radiotherapy

Intervention Type RADIATION

image guided radiotherapy without online adaptation

image guided radiotherapy without online adaptation

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

ECOG 0/1 No prior cancer treatment

Exclusion Criteria

ECOG 2-4 Prior cancer treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Maja Guberina

PD Dr. med. (MD) M. Guberina (senior consultant, specialist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maja Guberina

Essen, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Maja W Strahlentherapie

Role: primary

[email protected]
+492017232321

Other Identifiers

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23-11674-BO

Identifier Type: -

Identifier Source: org_study_id

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