Oropharynx Cancer Clinical Trial
— SENIOROfficial title:
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
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 |
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.
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 |
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 |
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 |
United States, Cyprus, Germany, Switzerland,
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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