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Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Study acronym: SENIOR
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026
    • Enrollment target: 1300 to 1500
    • Site details revised at 3 of 18 sites
    • Eligibility criteria shortened, about 2 words
    v6
  2. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024
    • Study sites: 14 to 18
    • Collaborators: 13 to 18
    v5
  3. Primary and study completion dates: Jun 2023 to Dec 31, 2023
    • Enrollment target: 1000 to 1300
    • Study sites: 12 to 14
    v4
  4. Primary and study completion dates: Jun 2022 to Jun 2023
    • Collaborators: 12 to 13
    v3
  5. Site details revised at 2 of 12 sitesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05337631
Lead Sponsor University Hospital Freiburg
Collaborators: Charite University, Berlin, Germany, Johann Wolfgang Goethe University Hospital, University Hospital, Zürich, Wuerzburg University Hospital, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz, University Hospital Munich, Friedrich-Alexander-Universität Erlangen-Nürnberg, Case Western Reserve University, Icahn School of Medicine at Mount Sinai, Ohio State University, German Oncology Center, Cyprus, University of Leipzig, Johns Hopkins University, Martin-Luther-Universität Halle-Wittenberg, University of Giessen, Brno University Hospital, Jena University Hospital
Conditions
(from sponsor)		 HNSCC, Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer
Related terms Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov