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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Johann Wolfgang Goethe University Hospital | OTHER |
| University Hospital, Zürich | OTHER |
| Wuerzburg University Hospital |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time from radiotherapy start until death from any cause | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of chemotherapy administration | Type of concomitant chemotherapy | during radiotherapy |
| Cumulative cisplatin dose | Dose of concomitant cisplatin in mg/m2 body surface area |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Rühle, MD, MHBA | Contact | 004976127095200 | alexander.ruehle@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine | Completed | Baltimore | Maryland | 21287 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2024 | Aug 22, 2024 |
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| OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| Johannes Gutenberg University Mainz | OTHER |
| University Hospital Munich | OTHER |
| Friedrich-Alexander-Universität Erlangen-Nürnberg | OTHER |
| Case Western Reserve University | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| Ohio State University | OTHER |
| German Oncology Center, Cyprus | OTHER |
| University of Leipzig | OTHER |
| Johns Hopkins University | OTHER |
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
| University of Giessen | OTHER |
| Brno University Hospital | OTHER |
| Jena University Hospital | OTHER |
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| during radiotherapy |
| Radiotherapy compliance | Radiotherapy completion rate | during treatment |
| Chemotherapy compliance | Chemotherapy completion rate | during treatment |
| Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai | Completed | New York | New York | 10017 | United States |
| Department of Radiation Oncology, Case Western Reserve University | Completed | Cleveland | Ohio | 10900 | United States |
| Division of Radiation Oncology, The Ohio State University Wexner | Completed | Columbus | Ohio | 43201 | United States |
| Radiation Oncology Department, German Oncology Center | Completed | Limassol | Cyprus |
| Brno University Hospital | Completed | Brno | Czechia |
| Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin | Completed | Berlin | Germany |
| Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg | Completed | Erlangen | Germany |
| Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main | Completed | Frankfurt | Germany |
| University of Giessen | Completed | Giessen | Germany |
| Martin-Luther-Universität Halle-Wittenberg | Completed | Halle | Germany |
| Jena University Hospital | Recruiting | Jena | Germany |
|
| Department of Radiation Oncology, University Hospital Schleswig-Holstein | Completed | Kiel | Germany |
| Department of Radiation Oncology, University Medical Center Leipzig | Completed | Leipzig | Germany |
| Department of Radiation Oncology, University Medical Center Mainz | Completed | Mainz | Germany |
| Department of Radiation Oncology, University Hospital, LMU Munich | Completed | Munich | Germany |
| Department of Radiation Oncology, University Hospital Würzburg | Completed | Würzburg | Germany |
| Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH) | Completed | Zurich | Switzerland |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
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