Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Oropharynx Cancer Clinical Trial

— SENIOR  

Official title:

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337631
• Other study ID #: FRKS003723
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University Hospital Freiburg
• Contact: Alexander Rühle, MD
• Phone: 004976127095200
• Email: alexander.ruehle[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• HNSCC
• Hypopharynx Cancer
• Laryngeal Neoplasms
• Larynx Cancer
• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Squamous Cell Carcinoma of Head and Neck

Locations

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

Sponsors (14)

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

Countries where clinical trial is conducted

United States,  Cyprus,  Germany,  Switzerland, 

Outcome

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