Adaptive radiotherapy for head and neck cancer patients
Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)
This study is testing a new type of radiation therapy for people with head and neck cancer to see if it can help them swallow better while still treating their cancer effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Essen) |
| Trial ID | NCT06216171 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adaptive radiotherapy (ART) in patients with head and neck cancers, specifically focusing on oropharyngeal and hypopharyngeal cancers. The study aims to optimize treatment by reducing radiation exposure to structures that can cause dysphagia and aspiration, thereby improving swallowing function. Participants will be randomly assigned to receive either dysphagia-optimized intensity-modulated radiotherapy (DO-IMRT) or standard IMRT. The trial seeks to establish ART as a new standard of care for enhancing patient quality of life during treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with newly diagnosed oropharyngeal or hypopharyngeal cancers who have an ECOG performance status of 0 or 1 and have not received prior cancer treatment.
Not a fit: Patients with an ECOG performance status of 2-4 or those who have previously undergone cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve swallowing function and quality of life for patients undergoing treatment for head and neck cancer.
How similar studies have performed: Previous studies have shown promising results with dysphagia-optimized IMRT, suggesting that this adaptive approach could lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ECOG 0/1 No prior cancer treatment Exclusion Criteria: ECOG 2-4 Prior cancer treatment
Where this trial is running
Essen
- Maja Guberina — Essen, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.