Adaptive Radiotherapy in Head and Neck Tumor Patients
ProHEART
Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2023
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2028
ExpectedSeptember 27, 2024
September 1, 2024
1.3 years
December 30, 2023
September 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EORTC CTC AE Score
quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017
2 months - 5 years
Dysphagia score
Dysphagia score
2 months - 5 years
Secondary Outcomes (2)
Overall Survival
2-5 years
Progression Free Survival
2-5 years
Study Arms (2)
Adaptive Radiotherapy
EXPERIMENTALAdaptive 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
ACTIVE COMPARATORStandard treatment option, image guided radiotherapy without online adaptation
Interventions
image guided radiotherapy without online adaptation
Eligibility Criteria
You may qualify if:
- ECOG 0/1 No prior cancer treatment
You may not qualify if:
- ECOG 2-4 Prior cancer treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maja Guberina
Essen, 45147, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. (MD) M. Guberina (senior consultant, specialist)
Study Record Dates
First Submitted
December 30, 2023
First Posted
January 22, 2024
Study Start
January 25, 2024
Primary Completion
April 30, 2025
Study Completion (Estimated)
January 30, 2028
Last Updated
September 27, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share