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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337631
Other study ID # FRKS003723
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source University Hospital Freiburg
Contact Alexander Rühle, MD
Phone 004976127095200
Email alexander.ruehle@uniklinik-freiburg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1300
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Cyprus Radiation Oncology Department, German Oncology Center Limassol
Germany 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 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
Switzerland Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH) Zürich
United States Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine Baltimore Maryland
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 Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai New York New York

Sponsors (14)

Lead Sponsor Collaborator
University Hospital Freiburg Case Western Reserve University, Charite University, Berlin, Germany, Friedrich-Alexander-Universität Erlangen-Nürnberg, German Oncology Center, Cyprus, Icahn School of Medicine at Mount Sinai, Johann Wolfgang Goethe University Hospital, Johannes Gutenberg University Mainz, Ohio State University, University Hospital Munich, University Hospital Schleswig-Holstein, University Hospital, Zürich, University of Leipzig, Wuerzburg University Hospital

Countries where clinical trial is conducted

United States,  Cyprus,  Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Patterns of chemotherapy administration Type of concomitant chemotherapy during radiotherapy
Other Cumulative cisplatin dose Dose of concomitant cisplatin in mg/m2 body surface area during radiotherapy
Other Radiotherapy compliance Radiotherapy completion rate during treatment
Other Chemotherapy compliance Chemotherapy completion rate during treatment
Primary Overall survival (OS) Time from radiotherapy start until death from any cause Up to 5 years
Secondary Progression-free survival (PFS) Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first) Up to 5 years
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