Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HNSCC, Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Cyprus, Czechia, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Overall survival (OS) [Time frame: Up to 5 years]
Secondary outcome measures (1)
- Progression-free survival (PFS) [Time frame: Up to 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 11 centers
- Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin — Berlin
- Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-Univer — Erlangen
- Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main — Frankfurt
- University of Giessen — Giessen
- Martin-Luther-Universität Halle-Wittenberg — Halle
- Jena University Hospital — Jena
- Department of Radiation Oncology, University Hospital Schleswig-Holstein — Kiel
- Department of Radiation Oncology, University Medical Center Leipzig — Leipzig
- … and 3 more centers
United States · 4 centers
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Universit — Baltimore
- Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai — New York
- Department of Radiation Oncology, Case Western Reserve University — Cleveland
- Division of Radiation Oncology, The Ohio State University Wexner — Columbus
Cyprus · 1 center
- Radiation Oncology Department, German Oncology Center — Limassol
Czechia · 1 center
- Brno University Hospital — Brno
Switzerland · 1 center
- Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich ( — Zurich
Identifiers
NCT: NCT05337631 · FRKS003723