Care patterns for elderly patients with head and neck cancer receiving radiotherapy
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
This study is looking at how well elderly patients with advanced head and neck cancer do with radiation treatment and chemotherapy to see if it helps them live longer and stay healthier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital Freiburg Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 18 sites (Baltimore, Maryland and 17 other locations) |
| Trial ID | NCT05337631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the oncological outcomes of elderly patients (aged 65 and older) with locally advanced head and neck squamous cell carcinoma (HNSCC) who are undergoing definitive (chemo-)radiotherapy. It will analyze the impact of concomitant chemotherapy on overall survival and progression-free survival while adjusting for confounding factors such as age and performance status. The study will utilize data from multiple centers to provide insights into the effectiveness of modern radiotherapy techniques and supportive treatments in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with locally advanced HNSCC undergoing definitive (chemo-)radiotherapy.
Not a fit: Patients with distant metastases, previous head-and-neck cancers, or those receiving adjuvant radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for elderly patients with head and neck cancer.
How similar studies have performed: While there is limited evidence specifically targeting elderly HNSCC patients, similar studies have shown that modern radiotherapy techniques can improve outcomes in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx * primary treatment since 2005 * age ≥65 years at the time of (chemo-)radiotherapy Exclusion Criteria: * adjuvant (chemo-)radiotherapy * history of previous head-and-neck cancers or radiotherapy in the head-and-neck region * distant metastases at (chemo-)radiotherapy initiation (cM1) * HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary
Where this trial is running
Baltimore, Maryland and 17 other locations
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Completed)
- Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai — New York, New York, United States (Completed)
- Department of Radiation Oncology, Case Western Reserve University — Cleveland, Ohio, United States (Completed)
- Division of Radiation Oncology, The Ohio State University Wexner — Columbus, Ohio, United States (Completed)
- Radiation Oncology Department, German Oncology Center — Limassol, Cyprus (Completed)
- Brno University Hospital — Brno, Czechia (Completed)
- Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin — Berlin, Germany (Completed)
- Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg — Erlangen, Germany (Completed)
- Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main — Frankfurt, Germany (Completed)
- University of Giessen — Giessen, Germany (Completed)
- Martin-Luther-Universität Halle-Wittenberg — Halle, Germany (Completed)
- Jena University Hospital — Jena, Germany (Recruiting)
- Department of Radiation Oncology, University Hospital Schleswig-Holstein — Kiel, Germany (Completed)
- Department of Radiation Oncology, University Medical Center Leipzig — Leipzig, Germany (Completed)
- Department of Radiation Oncology, University Medical Center Mainz — Mainz, Germany (Completed)
- Department of Radiation Oncology, University Hospital, LMU Munich — Munich, Germany (Completed)
- Department of Radiation Oncology, University Hospital Würzburg — Würzburg, Germany (Completed)
- Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH) — Zurich, Switzerland (Completed)
Study contacts
- Principal investigator: Nils H. Nicolay, MD, PhD — Department of Radiation Oncology, Medical Center - University of Freiburg
- Study coordinator: Alexander Rühle, MD, MHBA
- Email: alexander.ruehle@uniklinik-freiburg.de
- Phone: 004976127095200
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.