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NCT05337631 | RECRUITING | HNSCC


Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Sponsor:

University Hospital Freiburg

Information provided by (Responsible Party):

Nils Nicolay

Brief 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.

Condition or disease

HNSCC

Oral Cavity Cancer

Oropharynx Cancer

Hypopharynx Cancer

Larynx Cancer

Study Type : OBSERVATIONAL
Estimated Enrollment : 1500 participants
Official Title : Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Actual Study Start Date : 2021-06-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Location Details

NCT05337631


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


COMPLETED

United States, Maryland

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

Baltimore, Maryland, United States, 21287

COMPLETED

United States, New York

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

New York, New York, United States, 10017

COMPLETED

United States, Ohio

Department of Radiation Oncology, Case Western Reserve University

Cleveland, Ohio, United States, 10900

COMPLETED

United States, Ohio

Division of Radiation Oncology, The Ohio State University Wexner

Columbus, Ohio, United States, 43201

COMPLETED

Cyprus,

Radiation Oncology Department, German Oncology Center

Limassol, Cyprus,

COMPLETED

Czechia,

Brno University Hospital

Brno, Czechia,

COMPLETED

Germany,

Department of Radiooncology and Radiotherapy, Charité University Medicine Berlin

Berlin, Germany,

COMPLETED

Germany,

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

Erlangen, Germany,

COMPLETED

Germany,

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

Frankfurt, Germany,

COMPLETED

Germany,

University of Giessen

Pour, Germany,

COMPLETED

Germany,

Martin Luther University Halle-Wittenberg

Halle, Germany,

RECRUITING

Germany,

Jena University Hospital

Jena, Germany,

COMPLETED

Germany,

Department of Radiation Oncology, University Hospital Schleswig-Holstein

As, Germany,

COMPLETED

Germany,

Department of Radiation Oncology, University Medical Center Leipzig

Leipzig, Germany,

COMPLETED

Germany,

Department of Radiation Oncology, University Medical Center Mainz

Mainz, Germany,

COMPLETED

Germany,

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Germany,

COMPLETED

Germany,

Department of Radiation Oncology, University Hospital Würzburg

Würzburg, Germany,

COMPLETED

Switzerland,

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

Zürich, Switzerland,

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