Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Recruiting now
Conditions studied: HNSCC, Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer
In brief
The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.
Key facts
- Study ID
- NCT05337631
- Run by
- University Hospital Freiburg
- People needed
- 1500
- Starts
- 2021-06-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-03-25
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Jena University Hospital — Jena, Germany (enrolling)
- Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Department of Radiation Oncology, Case Western Reserve University — Cleveland, Ohio, United States
- Division of Radiation Oncology, The Ohio State University Wexner — Columbus, Ohio, United States
- Radiation Oncology Department, German Oncology Center — Limassol, Cyprus
- Brno University Hospital — Brno, Czechia
- Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin — Berlin, Germany
- Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg — Erlangen, Germany
- Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main — Frankfurt, Germany
- University of Giessen — Giessen, Germany
- Martin-Luther-Universität Halle-Wittenberg — Halle, Germany
- Department of Radiation Oncology, University Hospital Schleswig-Holstein — Kiel, Germany
- Department of Radiation Oncology, University Medical Center Leipzig — Leipzig, Germany
- Department of Radiation Oncology, University Medical Center Mainz — Mainz, Germany
- Department of Radiation Oncology, University Hospital, LMU Munich — Munich, Germany
- Department of Radiation Oncology, University Hospital Würzburg — Würzburg, Germany
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH) — Zurich, Switzerland
Full record on ClinicalTrials.gov
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