Clinical trial NCT05337631: Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Official title: Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HNSCC
Oral Cavity Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Keywords: Elderly
Radiotherapy
Chemotherapy
Chemoradiotherapy
Cisplatin
Cetuximab
Real-world data
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Johann Wolfgang Goethe University Hospital
name: University Hospital, Zürich
name: Wuerzburg University Hospital
name: University Hospital Schleswig-Holstein
name: Johannes Gutenberg University Mainz
name: University Hospital Munich
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Case Western Reserve University
name: Icahn School of Medicine at Mount Sinai
name: Ohio State University
name: German Oncology Center, Cyprus
name: University of Leipzig
name: Johns Hopkins University
name: Martin-Luther-Universität Halle-Wittenberg
name: University of Giessen
name: Brno University Hospital
name: Jena University Hospital
First posted: 2022-04-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
Other outcomes:
measure: Patterns of chemotherapy administration
timeFrame: during radiotherapy
measure: Cumulative cisplatin dose
timeFrame: during radiotherapy
measure: Radiotherapy compliance
timeFrame: during treatment
measure: Chemotherapy compliance
timeFrame: during treatment
Locations:
city: Baltimore
country: United States
facility: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
state: Maryland
city: New York
country: United States
facility: Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Department of Radiation Oncology, Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Division of Radiation Oncology, The Ohio State University Wexner
state: Ohio
city: Limassol
country: Cyprus
facility: Radiation Oncology Department, German Oncology Center
city: Brno
country: Czechia
facility: Brno University Hospital
city: Berlin
country: Germany
facility: Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin
city: Erlangen
country: Germany
facility: Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg
city: Frankfurt
country: Germany
facility: Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main
city: Gießen
country: Germany
facility: University of Giessen
city: Halle
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
city: Jena
country: Germany
facility: Jena University Hospital
city: Kiel
country: Germany
facility: Department of Radiation Oncology, University Hospital Schleswig-Holstein
city: Leipzig
country: Germany
facility: Department of Radiation Oncology, University Medical Center Leipzig
city: Mainz
country: Germany
facility: Department of Radiation Oncology, University Medical Center Mainz
city: Munich
country: Germany
facility: Department of Radiation Oncology, University Hospital, LMU Munich
city: Würzburg
country: Germany
facility: Department of Radiation Oncology, University Hospital Würzburg
city: Zürich
country: Switzerland
facility: Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)
Study officials:
affiliation: Department of Radiation Oncology, Medical Center - University of Freiburg
name: Nils H. Nicolay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Medical Center - University of Freiburg
name: Alexander Rühle, MD
role: PRINCIPAL_INVESTIGATOR
References: