Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- University Hospital Freiburg
- Study ID
- NCT05337631
- Status
- Recruiting
Conditions
- HNSCC
- Hypopharynx Cancer
- Larynx Cancer
- Oral Cavity Cancer
- Oropharynx Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Jun 1, 2021
- Status verified
- Mar 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 1,500 participants (estimated)
Primary Outcome Measure
Overall survival (OS) [ Time Frame: Up to 5 years ]
Central Contacts
- Alexander Rühle, MD, MHBA004976127095200
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | - |
| Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai | New York | New York | 10017 | - |
| Department of Radiation Oncology, Case Western Reserve University | Cleveland | Ohio | 10900 | - |
| Division of Radiation Oncology, The Ohio State University Wexner | Columbus | Ohio | 43201 | - |
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