Actively Recruiting

Age: 65Years +
All Genders
ID05337631

Special Care Patterns for Elderly Head-and-Neck Squamous Cell Carcinoma Patients Undergoing Radiotherapy

Led by University Hospital Freiburg · Updated on 2025-03-25

1500

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital Freiburg

Lead Sponsor

C

Charite University, Berlin, Germany

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating treatment outcomes in elderly patients aged 65 years and older with locally advanced head-and-neck squamous cell carcinomas (HNSCC) involving the oral cavity, oropharynx, hypopharynx, or larynx. The study aims to determine how definitive (chemo-)radiotherapy affects overall survival and progression-free survival in this vulnerable population, considering factors like age, performance status, and comorbidities. This retrospective multinational multicenter study addresses the limited evidence on optimal care for these patients. The study observes patients who have undergone definitive (chemo-)radiotherapy since 2005, focusing on modern radiotherapy techniques such as intensity-modulated radiotherapy (IMRT) and varying chemotherapy schedules, including weekly cisplatin. It assesses the impact of these treatments on survival outcomes and investigates the role of concomitant chemotherapy in this elderly cohort. Participants' medical records are reviewed to collect data on overall survival up to five years and progression-free survival up to five years after treatment initiation. Researchers analyze patient characteristics, treatment details, and outcomes to understand the influence of therapy choices on survival. The study involves no new interventions or procedures, relying on existing clinical data from multiple centers.

CONDITIONS

Brief Title

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 years or older at the time of definitive (chemo-)radiotherapy
  • Diagnosed with locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Primary treatment with definitive (chemo-)radiotherapy since 2005
Not Eligible

You will not qualify if you...

  • Receiving adjuvant (chemo-)radiotherapy
  • History of previous head-and-neck cancers or prior radiotherapy in the head-and-neck region
  • Presence of distant metastases at the start of (chemo-)radiotherapy (cM1)
  • Head-and-neck squamous cell carcinomas of the nasopharynx, salivary glands, skin, or unknown primary site

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are observed to assess overall survival and progression-free survival after their definitive (chemo-)radiotherapy treatment.

Periodic visits depending on clinical follow-up schedules

Trial Site Locations

Total: 18 locations

1

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Completed

2

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10017

Completed

3

Department of Radiation Oncology, Case Western Reserve University

Cleveland, Ohio, United States, 10900

Completed

4

Division of Radiation Oncology, The Ohio State University Wexner

Columbus, Ohio, United States, 43201

Completed

5

Radiation Oncology Department, German Oncology Center

Limassol, Cyprus

Completed

6

Brno University Hospital

Brno, Czechia

Completed

7

Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin

Berlin, Germany

Completed

8

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

Erlangen, Germany

Completed

9

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

Frankfurt, Germany

Completed

10

University of Giessen

Giessen, Germany

Completed

11

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany

Completed

12

Jena University Hospital

Jena, Germany

Actively Recruiting

13

Department of Radiation Oncology, University Hospital Schleswig-Holstein

Kiel, Germany

Completed

14

Department of Radiation Oncology, University Medical Center Leipzig

Leipzig, Germany

Completed

15

Department of Radiation Oncology, University Medical Center Mainz

Mainz, Germany

Completed

16

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Germany

Completed

17

Department of Radiation Oncology, University Hospital Würzburg

Würzburg, Germany

Completed

18

Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)

Zurich, Switzerland

Completed

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Research Team

A

Alexander Rühle, MD, MHBA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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