Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

NCT05337631 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-03-25

No results posted yet for this study

Summary

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.

Conditions

  • HNSCC
  • Oral Cavity Cancer
  • Oropharynx Cancer
  • Hypopharynx Cancer
  • Larynx Cancer

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER
  • Johann Wolfgang Goethe University Hospital

    collaborator OTHER
  • University Hospital, Zürich

    collaborator OTHER
  • Wuerzburg University Hospital

    collaborator OTHER
  • University Hospital Schleswig-Holstein

    collaborator OTHER
  • Johannes Gutenberg University Mainz

    collaborator OTHER
  • University Hospital Munich

    collaborator OTHER
  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    collaborator OTHER
  • Case Western Reserve University

    collaborator OTHER
  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • German Oncology Center, Cyprus

    collaborator OTHER
  • University of Leipzig

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Martin-Luther-Universität Halle-Wittenberg

    collaborator OTHER
  • University of Giessen

    collaborator OTHER
  • Brno University Hospital

    collaborator OTHER
  • Jena University Hospital

    collaborator OTHER
  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Nils H. Nicolay, MD, PhD · Department of Radiation Oncology, Medical Center - University of Freiburg

  • Alexander Rühle, MD · Department of Radiation Oncology, Medical Center - University of Freiburg

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States
  • Cyprus
  • Czechia
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337631 on ClinicalTrials.gov