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Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy (SENIOR)

U

University Hospital Freiburg

Status

Enrolling

Conditions

Oropharynx Cancer
Hypopharynx Cancer
Oral Cavity Cancer
HNSCC
Larynx Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05337631
FRKS003723

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

18

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Central trial contact

Alexander Rühle, MD, MHBA

Data sourced from clinicaltrials.gov

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