RECRUITING

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Quick Facts

Study Start:2021-06-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05337631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * primary treatment between 2005 and 2019
  3. * age ≥65 years at the time of (chemo-)radiotherapy
  1. * adjuvant (chemo-)radiotherapy
  2. * history of previous head-and-neck cancers or radiotherapy in the head-and-neck region
  3. * distant metastases at (chemo-)radiotherapy initiation (cM1)
  4. * HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary

Contacts and Locations

Study Contact

Alexander Rühle, MD, MHBA
CONTACT
004976127095200
alexander.ruehle@uniklinik-freiburg.de

Principal Investigator

Nils H. Nicolay, MD, PhD
PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Medical Center - University of Freiburg
Alexander Rühle, MD
PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Medical Center - University of Freiburg

Study Locations (Sites)

Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States
Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
New York, New York, 10017
United States
Department of Radiation Oncology, Case Western Reserve University
Cleveland, Ohio, 10900
United States
Division of Radiation Oncology, The Ohio State University Wexner
Columbus, Ohio, 43201
United States

Collaborators and Investigators

Sponsor: University Hospital Freiburg

  • Nils H. Nicolay, MD, PhD, PRINCIPAL_INVESTIGATOR, Department of Radiation Oncology, Medical Center - University of Freiburg
  • Alexander Rühle, MD, PRINCIPAL_INVESTIGATOR, Department of Radiation Oncology, Medical Center - University of Freiburg

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Elderly
  • Radiotherapy
  • Chemotherapy
  • Chemoradiotherapy
  • Cisplatin
  • Cetuximab
  • Real-world data

Additional Relevant MeSH Terms

  • HNSCC
  • Oral Cavity Cancer
  • Oropharynx Cancer
  • Hypopharynx Cancer
  • Larynx Cancer