Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

NCT05337631 | Recruiting

• 1 other identifier: FRKS003723
• Study Type: observational
• Target: 1,500
• Locations: 5 countries
• Sites: 18

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.

Conditions

HNSCC; Oral Cavity Cancer; Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer

Keywords

Elderly; Radiotherapy; Chemotherapy; Chemoradiotherapy; Cisplatin; Cetuximab; Real-world data

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Time from radiotherapy start until death from any cause

  Up to 5 years

Secondary Outcomes (1)

• Progression-free survival (PFS)

  Up to 5 years

Other Outcomes (4)

• Patterns of chemotherapy administration

  during radiotherapy

• Cumulative cisplatin dose

  during radiotherapy

• Radiotherapy compliance

  during treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Charite University, Berlin, Germany: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• University Hospital, Zürich: collaborator
• Wuerzburg University Hospital: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Munich: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• Case Western Reserve University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Ohio State University: collaborator
• German Oncology Center, Cyprus: collaborator
• University of Leipzig: collaborator
• Johns Hopkins University: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• University of Giessen: collaborator
• Brno University Hospital: collaborator
• Jena University Hospital: collaborator

Study Sites (18)

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

Baltimore, Maryland, 21287, United States

COMPLETED

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

New York, New York, 10017, United States

COMPLETED

Department of Radiation Oncology, Case Western Reserve University

Cleveland, Ohio, 10900, United States

COMPLETED

Division of Radiation Oncology, The Ohio State University Wexner

Columbus, Ohio, 43201, United States

COMPLETED

Radiation Oncology Department, German Oncology Center

Limassol, Cyprus

COMPLETED

Brno University Hospital

Brno, Czechia

COMPLETED

Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin

Berlin, Germany

COMPLETED

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

Erlangen, Germany

COMPLETED

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

Frankfurt, Germany

COMPLETED

University of Giessen

Giessen, Germany

COMPLETED

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany

COMPLETED

Jena University Hospital

Jena, Germany

RECRUITING

Department of Radiation Oncology, University Hospital Schleswig-Holstein

Kiel, Germany

COMPLETED

Department of Radiation Oncology, University Medical Center Leipzig

Leipzig, Germany

COMPLETED

Department of Radiation Oncology, University Medical Center Mainz

Mainz, Germany

COMPLETED

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Germany

COMPLETED

Department of Radiation Oncology, University Hospital Würzburg

Würzburg, Germany

COMPLETED

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

Zurich, Switzerland

COMPLETED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Nils H. Nicolay, MD, PhD

  Department of Radiation Oncology, Medical Center - University of Freiburg

  PRINCIPAL INVESTIGATOR

• Alexander Rühle, MD

  Department of Radiation Oncology, Medical Center - University of Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Rühle, MD, MHBA

CONTACT

004976127095200; alexander.ruehle@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, Department of Radiation Oncology

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 20, 2022
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); CY (1); US (4); CZ (1); CH (1)