Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Recruiting

• Conditions: Hypopharynx Cancer; HNSCC; Oral Cavity Cancer; Oropharynx Cancer; Larynx Cancer

• Registration Number: NCT05337631
• Lead Sponsor: University Hospital Freiburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 5 years	Time from radiotherapy start until death from any cause

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 5 years	Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first)

Trial Locations

Locations (18)

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Department of Radiation Oncology, Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Division of Radiation Oncology, The Ohio State University Wexner; 🇺🇸 Columbus, Ohio, United States

Radiation Oncology Department, German Oncology Center; 🇨🇾 Limassol, Cyprus

Brno University Hospital; 🇨🇿 Brno, Czechia

Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg; 🇩🇪 Erlangen, Germany

Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main; 🇩🇪 Frankfurt, Germany

University of Giessen; 🇩🇪 Gießen, Germany

Martin-Luther-Universität Halle-Wittenberg; 🇩🇪 Halle, Germany

Jena University Hospital; 🇩🇪 Jena, Germany

Department of Radiation Oncology, University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

Department of Radiation Oncology, University Medical Center Leipzig; 🇩🇪 Leipzig, Germany

Department of Radiation Oncology, University Medical Center Mainz; 🇩🇪 Mainz, Germany

Department of Radiation Oncology, University Hospital, LMU Munich; 🇩🇪 Munich, Germany

Department of Radiation Oncology, University Hospital Würzburg; 🇩🇪 Würzburg, Germany

Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH); 🇨🇭 Zürich, Switzerland