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NCT Number: NCT05337631

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

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.

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Key information

Conditions

HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cavity Cancer Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiation Oncology Department, German Oncology Center, Limassol, Cyprus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years

    Time from radiotherapy start until death from any cause

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 5 years

    Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first)

Other outcomes

  1. Patterns of chemotherapy administration

    Time frame: during radiotherapy

    Type of concomitant chemotherapy

  2. Cumulative cisplatin dose

    Time frame: during radiotherapy

    Dose of concomitant cisplatin in mg/m2 body surface area

  3. Radiotherapy compliance

    Time frame: during treatment

    Radiotherapy completion rate

  4. Chemotherapy compliance

    Time frame: during treatment

    Chemotherapy completion rate

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Rühle, MD, MHBA

CONTACT

[email protected]

004976127095200

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Collaborators

  • Brno University Hospital
  • Case Western Reserve University
  • Charite University, Berlin, Germany
  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • German Oncology Center, Cyprus
  • Icahn School of Medicine at Mount Sinai
  • Jena University Hospital
  • Johann Wolfgang Goethe University Hospital
  • Johannes Gutenberg University Mainz
  • Johns Hopkins University
  • Martin-Luther-Universität Halle-Wittenberg
  • Ohio State University
  • University Hospital Munich
  • University Hospital Schleswig-Holstein
  • University Hospital, Zürich
  • University of Giessen
  • University of Leipzig
  • Wuerzburg University Hospital

Registry information

Acronym: SENIOR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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