Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

Completed · Not applicable

Conditions studied: Head and Neck Squamous Cell Carcinoma (HNSCC)

In brief

The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older. Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.

Key facts

Study ID

NCT04284540

Run by

Icahn School of Medicine at Mount Sinai

People needed

37

Starts

2019-07-01

Expected to finish

2025-06-12

Last updated by the study team

2026-02-03

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 70 years.
• No previous RT or chemotherapy for HNSCC is allowed at time of study entry.
• Life expectancy > 12 weeks.
• Participants must have histologically or cytologically confirmed diagnosis of HNSCC: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary)
• All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5
• Non-concurrent chemotherapy
• First line treatment
• Anyone eligible for definitive or adjuvant based RT therapy
• Adjuvant therapy when histopathological factors (advanced T category, nodal disease, lymphovascular or perineural invasion, high-grade, or positive margins)
• Anyone being treated with curative intent
• Unfit as determined by the treating physician and ECOG performance 1, 2, or 3 (Appendix 2).
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if…

• Patients < 70
• Metastatic disease outside of the head and neck
• Pregnancy
• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.
• Prior RT of head and neck area
• Concurrent chemotherapy or immunotherapy or hormonotherapy
• Any comorbid connective tissue disorder which could aggravate RT associated toxicities (e.g. Scleroderma)
• In cases where patients cannot consent on their own due to underlying dementia, we can consent the patient's healthcare proxy

Where it is running

• Mount Sinai Downtown Union Square — New York, New York, United States
• Mount Sinai Chelsea — New York, New York, United States
• Mount Sinai West — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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