ClinicalTrials.gg
RecruitingNCT05337631SENIORUpdated Mar 25, 2025

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

An observational study in HNSCC, Oral Cavity Cancer and Oropharynx Cancer, sponsored by University Hospital Freiburg. Recruiting at 18 sites in 5 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by University Hospital Freiburg · Observational

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany — 34 open to participants now, 50 under way, 14 of them phase 3. Squamous Cell Carcinoma of Head and Neck · Germany.

Planned enrollment
3rd of 12
1,500 · median 331
Started
2021
with 15 others
Observational
12 of 116
9 open now
Primary completion
2026-12
later than 14 of 49 live
Registered
80th of 116
by date

Among the 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany, this one is the 3rd largest by planned enrollment of the 12 observational ones, is one of 16 that started in 2021, is one of 12 observational ones, reaches primary completion later than 14 of the 49 other live ones, and was the 80th registered.

By phase

116 studies; the count open now beside each. This study's row is marked.

Phase 240 · 6 open
Phase 324 · 7 open
Phase 117 · 2 open
Phase 1/213 · 6 open
Observationalthis study12 · 9 open
No phase5 · 2 open
Phase 2/35 · 2 open

By the year they started

First in 1999; this study’s year is marked. 16 started in 2021.

Size and results

Median enrollment 178 across the 104 interventional studies, 331 across the 12 observational. Of the 61 that completed or were terminated, 25 (41%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • HNSCC
  • Oral Cavity Cancer
  • Oropharynx Cancer
  • Hypopharynx Cancer
  • Larynx Cancer

Keywords

  • Elderly
  • Radiotherapy
  • Chemotherapy
  • Chemoradiotherapy
  • Cisplatin
  • Cetuximab
  • Real-world data
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • (chemo-)radiotherapy
  • history of previous head-and-neck cancers or radiotherapy in the head-and-neck region
  • distant at (chemo-)radiotherapy initiation (cM1)
  • HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Time from radiotherapy start until death from any cause

    Time frame: 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)

    Time frame: Up to 5 years

Other outcomes

  1. Patterns of chemotherapy administration

    Type of concomitant chemotherapy

    Time frame: during radiotherapy

  2. Cumulative cisplatin dose

    Dose of concomitant cisplatin in mg/m2 body surface area

    Time frame: during radiotherapy

  3. Radiotherapy compliance

    Radiotherapy completion rate

    Time frame: during treatment

  4. Chemotherapy compliance

    Chemotherapy completion rate

    Time frame: during treatment

07

Study locations

1 of 18 sites recruiting
  • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
    New York, New York 10017, United States
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, Case Western Reserve University
    Cleveland, Ohio 10900, United States
    Completed

    Not enrolling at this site.

  • Division of Radiation Oncology, The Ohio State University Wexner
    Columbus, Ohio 43201, United States
    Completed

    Not enrolling at this site.

  • Radiation Oncology Department, German Oncology Center
    Limassol, Cyprus
    Completed

    Not enrolling at this site.

  • Brno University Hospital
    Brno, Czechia
    Completed

    Not enrolling at this site.

  • Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
    Berlin, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
    Erlangen, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
    Frankfurt, Germany
    Completed

    Not enrolling at this site.

  • University of Giessen
    Gießen, Germany
    Completed

    Not enrolling at this site.

  • Martin-Luther-Universität Halle-Wittenberg
    Halle, Germany
    Completed

    Not enrolling at this site.

  • Jena University Hospital
    Jena, Germany
    Recruiting
    • Klaus Pietschmann, MD · Contact
  • Department of Radiation Oncology, University Hospital Schleswig-Holstein
    Kiel, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Medical Center Leipzig
    Leipzig, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Medical Center Mainz
    Mainz, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Hospital, LMU Munich
    Munich, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Hospital Würzburg
    Würzburg, Germany
    Completed

    Not enrolling at this site.

  • Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
    Zürich, Switzerland
    Completed

    Not enrolling at this site.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2021 (actual). Primary completion is estimated for Dec 2026, 66 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2022
First posted
Apr 20, 2022
StartActual
Jun 1, 2021
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Mar 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
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
Responsible party
Nils Nicolay (Professor and Vice Chair, Department of Radiation Oncology, University Hospital Freiburg) — Principal investigator
First posted
Apr 20, 2022
Start date
Jun 1, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 25, 2025

Study contacts

Alexander Rühle, MD, MHBA
Contact
alexander.ruehle@uniklinik-freiburg.de
004976127095200
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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