About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Elderly (≥65 years) head-and-neck squamous cell carcinoma (HNSCC) patients undergoing definitive (chemo)radiotherapy since 2005 at a tertiary cancer center will be included and analyzed in terms of overall survival and the potential benefit of concomitant chemotherapy administration.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival (OS)
Time from radiotherapy start until death from any cause
Secondary outcomes
Progression-free survival (PFS)
Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first)
Other outcomes
Patterns of chemotherapy administration
Type of concomitant chemotherapy
Cumulative cisplatin dose
Dose of concomitant cisplatin in mg/m2 body surface area
Radiotherapy compliance
Radiotherapy completion rate
Chemotherapy compliance
Chemotherapy completion rate
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Freiburg
Lead sponsor
Charite University, Berlin, Germany
Collaborator
Johann Wolfgang Goethe University Hospital
Collaborator
University Hospital, Zürich
Collaborator
Wuerzburg University Hospital
Collaborator
University Hospital Schleswig-Holstein
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University Hospital Munich
Collaborator
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborator
Case Western Reserve University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Ohio State University
Collaborator
German Oncology Center, Cyprus
Collaborator
University of Leipzig
Collaborator
Johns Hopkins University
Collaborator
Martin-Luther-Universität Halle-Wittenberg
Collaborator
University of Giessen
Collaborator
Brno University Hospital
Collaborator
Jena University Hospital
Collaborator