Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Last updated: March 24, 2025
Sponsor: University Hospital Freiburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Oral Cavity Cancer

Treatment

N/A

Clinical Study ID

NCT05337631
FRKS003723
  • Ages > 65
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • adjuvant (chemo-)radiotherapy

  • history of previous head-and-neck cancers or radiotherapy in the head-and-neckregion

  • distant metastases at (chemo-)radiotherapy initiation (cM1)

  • HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary

Study Design

Total Participants: 1500
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Radiation Oncology Department, German Oncology Center

    Limassol,
    Cyprus

    Completed

  • Brno University Hospital

    Brno,
    Czechia

    Completed

  • Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin

    Berlin,
    Germany

    Completed

  • Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg

    Erlangen,
    Germany

    Completed

  • Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main

    Frankfurt,
    Germany

    Completed

  • University of Giessen

    Gießen,
    Germany

    Completed

  • Martin-Luther-Universität Halle-Wittenberg

    Halle,
    Germany

    Completed

  • Jena University Hospital

    Jena,
    Germany

    Active - Recruiting

  • Department of Radiation Oncology, University Hospital Schleswig-Holstein

    Kiel,
    Germany

    Completed

  • Department of Radiation Oncology, University Medical Center Leipzig

    Leipzig,
    Germany

    Completed

  • Department of Radiation Oncology, University Medical Center Mainz

    Mainz,
    Germany

    Completed

  • Department of Radiation Oncology, University Hospital, LMU Munich

    Munich,
    Germany

    Completed

  • Department of Radiation Oncology, University Hospital Würzburg

    Würzburg,
    Germany

    Completed

  • Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)

    Zürich,
    Switzerland

    Completed

  • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Completed

  • Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai

    New York, New York 10017
    United States

    Completed

  • Department of Radiation Oncology, Case Western Reserve University

    Cleveland, Ohio 10900
    United States

    Completed

  • Division of Radiation Oncology, The Ohio State University Wexner

    Columbus, Ohio 43201
    United States

    Completed

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