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RecruitingObservational

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

NCT ID: NCT05337631Sponsor: University Hospital FreiburgLast updated: 2025-03-25

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.

Outcome measures

Primary

  • Overall survival (OS)

    Time from radiotherapy start until death from any cause

    Time frame: Up to 5 years

Secondary

  • Progression-free survival (PFS)

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 65 Years and olderHealthy volunteers: No
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

Study locations (4)

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Completed

Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai

New York, New York, 10017

Completed

Department of Radiation Oncology, Case Western Reserve University

Cleveland, Ohio, 10900

Completed

Division of Radiation Oncology, The Ohio State University Wexner

Columbus, Ohio, 43201

Completed
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy | Cancerify