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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.
Conditions:
🦠 HNSCC 🦠 Oral Cavity Cancer 🦠 Oropharynx Cancer 🦠 Hypopharynx Cancer 🦠 Larynx Cancer
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) 31 December 2023
✅ Study Completion (Estimated) 31 December 2023
👥 Enrollment (Estimated) 1300
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Baltimore, Maryland, United States
📍 New York, New York, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Limassol, Cyprus
📍 Berlin, Germany
📍 Erlangen, Germany
📍 Frankfurt, Germany
📍 Kiel, Germany
📍 Leipzig, Germany
📍 Mainz, Germany
📍 Munich, Germany
📍 Würzburg, Germany
📍 Zürich, Switzerland
More locations available...

📋 Eligibility Criteria

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 between 2005 and 2019
    • * 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
Ages Eligible for Study: 65 Years to N/A (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 March 2022
  • First Submitted that Met QC Criteria 14 April 2022
  • First Posted 20 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 July 2023
  • Last Update Posted 24 July 2023
  • Last Verified July 2023
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