Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy (SENIOR)

March 24, 2025 updated by: Nils Nicolay, University Hospital Freiburg
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Cyprus
      • Limassol, Cyprus
        • Completed
        • Radiation Oncology Department, German Oncology Center
  • Czechia
      • Brno, Czechia
        • Completed
        • Brno University Hospital
  • Germany
      • Berlin, Germany
        • Completed
        • Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
      • Erlangen, Germany
        • Completed
        • Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
      • Frankfurt, Germany
        • Completed
        • Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
      • Gießen, Germany
        • Completed
        • University of Giessen
      • Halle, Germany
        • Completed
        • Martin-Luther-Universität Halle-Wittenberg
      • Jena, Germany
        • Recruiting
        • Jena University Hospital
        • Contact:
          • Klaus Pietschmann, MD
      • Kiel, Germany
        • Completed
        • Department of Radiation Oncology, University Hospital Schleswig-Holstein
      • Leipzig, Germany
        • Completed
        • Department of Radiation Oncology, University Medical Center Leipzig
      • Mainz, Germany
        • Completed
        • Department of Radiation Oncology, University Medical Center Mainz
      • Munich, Germany
        • Completed
        • Department of Radiation Oncology, University Hospital, LMU Munich
      • Würzburg, Germany
        • Completed
        • Department of Radiation Oncology, University Hospital Würzburg
  • Switzerland
      • Zürich, Switzerland
        • Completed
        • Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Completed
        • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
    • New York
      • New York, New York, United States, 10017
        • Completed
        • Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
    • Ohio
      • Cleveland, Ohio, United States, 10900
        • Completed
        • Department of Radiation Oncology, Case Western Reserve University
      • Columbus, Ohio, United States, 43201
        • Completed
        • Division of Radiation Oncology, The Ohio State University Wexner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly (≥65 years) head-and-neck squamous cell carcinoma (HNSCC) patients undergoing definitive (chemo)radiotherapy since 2005 at a tertiary cancer center will be included and analyzed in terms of overall survival and the potential benefit of concomitant chemotherapy administration.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 5 years
Time from radiotherapy start until death from any cause
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Up to 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patterns of chemotherapy administration
Time Frame: during radiotherapy
Type of concomitant chemotherapy
during radiotherapy
Cumulative cisplatin dose
Time Frame: during radiotherapy
Dose of concomitant cisplatin in mg/m2 body surface area
during radiotherapy
Radiotherapy compliance
Time Frame: during treatment
Radiotherapy completion rate
during treatment
Chemotherapy compliance
Time Frame: during treatment
Chemotherapy completion rate
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Freiburg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Charite University, Berlin, Germany
Icahn School of Medicine at Mount Sinai
Ohio State University
University of Leipzig
Johann Wolfgang Goethe University Hospital
Case Western Reserve University
University Hospital Schleswig-Holstein
Johannes Gutenberg University Mainz
University Hospital, Zürich
University of Giessen
Martin-Luther-Universität Halle-Wittenberg
German Oncology Center, Cyprus
Brno University Hospital
Wuerzburg University Hospital
University Hospital Munich
Jena University Hospital
Friedrich-Alexander-Universität Erlangen-Nürnberg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nils H. Nicolay, MD, PhD, Department of Radiation Oncology, Medical Center - University of Freiburg
  • Principal Investigator: Alexander Rühle, MD, Department of Radiation Oncology, Medical Center - University of Freiburg

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FRKS003723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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