Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy (SENIOR)

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharynx Cancer; Oral Cavity Cancer; Larynx Cancer; HNSCC; Hypopharynx Cancer

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Alexander Rühle, MD, MHBA; Phone Number: 004976127095200; Email: alexander.ruehle@uniklinik-freiburg.de

Study Locations

• Cyprus
  • Limassol, Cyprus
    • Completed
    • Radiation Oncology Department, German Oncology Center
• Czechia
  • Brno, Czechia
    • Completed
    • Brno University Hospital
• Germany
  • Berlin, Germany
    • Completed
    • Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
  • Erlangen, Germany
    • Completed
    • Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
  • Frankfurt, Germany
    • Completed
    • Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
  • Gießen, Germany
    • Completed
    • University of Gießen
  • Halle, Germany
    • Completed
    • Martin-Luther-Universität Halle-Wittenberg
  • Jena, Germany
    • Recruiting
    • Jena University Hospital
    • Contact: Klaus Pietschmann, MD
  • Kiel, Germany
    • Completed
    • Department of Radiation Oncology, University Hospital Schleswig-Holstein
  • Leipzig, Germany
    • Completed
    • Department of Radiation Oncology, University Medical Center Leipzig
  • Mainz, Germany
    • Completed
    • Department of Radiation Oncology, University Medical Center Mainz
  • Munich, Germany
    • Completed
    • Department of Radiation Oncology, University Hospital, LMU Munich
  • Würzburg, Germany
    • Completed
    • Department of Radiation Oncology, University Hospital Würzburg
• Switzerland
  • Zürich, Switzerland
    • Completed
    • Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Completed
      • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
  • New York
    • New York, New York, United States, 10017
      • Completed
      • Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cleveland, Ohio, United States, 10900
      • Completed
      • Department of Radiation Oncology, Case Western Reserve University
    • Columbus, Ohio, United States, 43201
      • Completed
      • Division of Radiation Oncology, The Ohio State University Wexner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from radiotherapy start until death from any cause	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first)	Up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patterns of chemotherapy administration	Type of concomitant chemotherapy	during radiotherapy
Cumulative cisplatin dose	Dose of concomitant cisplatin in mg/m2 body surface area	during radiotherapy
Radiotherapy compliance	Radiotherapy completion rate	during treatment
Chemotherapy compliance	Chemotherapy completion rate	during treatment

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Collaborators: Johns Hopkins University; Charite University, Berlin, Germany; Icahn School of Medicine at Mount Sinai; Ohio State University; University of Leipzig; Johann Wolfgang Goethe University Hospital; Case Western Reserve University; University Hospital Schleswig-Holstein; Johannes Gutenberg University Mainz; University Hospital, Zürich; University of Giessen; Martin-Luther-Universität Halle-Wittenberg; German Oncology Center, Cyprus; Brno University Hospital; Wuerzburg University Hospital; University Hospital Munich; Jena University Hospital; Friedrich-Alexander-Universität Erlangen-Nürnberg
• Investigators: Principal Investigator: Nils H. Nicolay, MD, PhD, Department of Radiation Oncology, Medical Center - University of Freiburg; Principal Investigator: Alexander Rühle, MD, Department of Radiation Oncology, Medical Center - University of Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Cisplatin; Radiotherapy; Chemotherapy; Cetuximab; Chemoradiotherapy; Real-world data
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Carcinoma, Squamous Cell; Laryngeal Diseases; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms
• Other Study ID Numbers: FRKS003723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No