HNSCCSENIORNCT05337631
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
An observational study of HNSCC and Oral Cavity Cancer, run by University Hospital Freiburg at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HNSCC, Oral Cavity Cancer, Oropharynx Cancer
- How many people
- 1,500 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 5 countries
Germany11 sites, 1 recruiting
- Completed
Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
Berlin
- Completed
Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
Erlangen
- Completed
Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
Frankfurt
- Completed
University of Giessen
Giessen
- Completed
Martin-Luther-Universität Halle-Wittenberg
Halle
- Recruiting
Jena University Hospital
Jena
Klaus Pietschmann, MD
- Completed
Department of Radiation Oncology, University Hospital Schleswig-Holstein
Kiel
- Completed
Department of Radiation Oncology, University Medical Center Leipzig
Leipzig
- Completed
Department of Radiation Oncology, University Medical Center Mainz
Mainz
- Completed
Department of Radiation Oncology, University Hospital, LMU Munich
Munich
- Completed
Department of Radiation Oncology, University Hospital Würzburg
Würzburg
United States4 sites
- Completed
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
- Completed
Department of Radiation Oncology, Case Western Reserve University
Cleveland, Ohio, 10900
- Completed
Division of Radiation Oncology, The Ohio State University Wexner
Columbus, Ohio, 43201
- Completed
Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
New York, New York, 10017
Cyprus1 site
- Completed
Radiation Oncology Department, German Oncology Center
Limassol
Switzerland1 site
- Completed
Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
Zurich
About this study
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
- Keywords
- Elderly, Radiotherapy, Chemotherapy, Chemoradiotherapy, Cisplatin, Cetuximab, Real-world data
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from radiotherapy start until death from any cause
Measured: Up to 5 years
Secondary outcomes (1)
Progression-free survival (PFS)
Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Nils Nicolay, University Hospital Freiburg
- Investigators
- Nils H. Nicolay, MD, PhD, Principal investigator, Department of Radiation Oncology, Medical Center - University of FreiburgAlexander Rühle, MD, Principal investigator, Department of Radiation Oncology, Medical Center - University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337631
- Sponsor's protocol ID
- FRKS003723
- Acronym
- SENIOR
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT05337631
- Acronym / sponsor ID
- SENIOR / FRKS003723
- Conditions
- HNSCC, Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer
- Keywords
- Elderly, Radiotherapy, Chemotherapy, Chemoradiotherapy, Cisplatin, Cetuximab, Real-world data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- 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
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: Up to 5 years
Time from radiotherapy start until death from any cause
1 secondary outcome
Progression-free survival (PFS)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nils H. Nicolay, MD, PhD principal investigator
Department of Radiation Oncology, Medical Center - University of Freiburg
Alexander Rühle, MD principal investigator
Department of Radiation Oncology, Medical Center - University of Freiburg
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HNSCC and Oral Cavity Cancer, run by University Hospital Freiburg at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, United States, Cyprus, Czechia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rühle, MD, MHBA (004976127095200, alexander.ruehle@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.