Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

Studienbeginn:
Juni 2021

Letztes Update:
24.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Freiburg

Collaborator:
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-Alexan

Studienleiter

Nils H. Nicolay, MD, PhD
Principal Investigator
Department of Radiation Oncology, Medical Center - University of Freiburg

Kontakt

Alexander Rühle, MD
Kontakt:
Phone: 004976127095200
E-Mail: alexander.ruehle@uniklinik-freiburg.de» Kontaktdaten anzeigen

Studienlocations
(3 von 14)

Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
Erlangen
(Bayern)
GermanyAbgeschlossen» Google-Maps

Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
Frankfurt
(Hessen)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Hospital Schleswig-Holstein
Kiel
(Schleswig-Holstein)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Medical Center Leipzig
Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nils H Nicolay, MD, PhD
E-Mail: nils.nicolay@medizin.uni-leipzig.de

Alexander Rühle, MD
E-Mail: alexander.ruehle@medizin.uni-leipzig.de» Ansprechpartner anzeigen

Department of Radiation Oncology, University Medical Center Mainz
Mainz
(Rheinland-Pfalz)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Hospital, LMU Munich
Munich
(Bayern)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Hospital Würzburg
Würzburg
(Bayern)
GermanyAbgeschlossen» Google-Maps

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
21287 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Harry Quon, MD, MS

Carmen Kut, MD, PhD» Ansprechpartner anzeigen

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
10017 New York
United StatesAbgeschlossen» Google-Maps

Department of Radiation Oncology, Case Western Reserve University
10900 Cleveland
United StatesAbgeschlossen» Google-Maps

Division of Radiation Oncology, The Ohio State University Wexner
43201 Columbus
United StatesAbgeschlossen» Google-Maps

Radiation Oncology Department, German Oncology Center
Limassol
CyprusAbgeschlossen» Google-Maps

Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
Zürich
SwitzerlandAbgeschlossen» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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 between 2005 and 2019

- 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

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - Up to 5 years):
Time from radiotherapy start until death from any cause

Secondary outcome:

1. 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)

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!