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NCT04284540Completed

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

A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 3 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
37 (actual)
First submitted
24 Feb 2020
Start date
1 Jul 2019
Primary completion date
7 Nov 2024
Lead sponsor
Icahn School of Medicine at Mount Sinai
NCT number
NCT04284540

What you commit to

  • Study type: Interventional
  • Participants enrolled: 37
  • From 1 Jul 2019 to the primary completion date, 7 Nov 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Metastatic disease outside of the head and neck
  • 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

Other

  • Patients \< 70
  • Pregnancy

Who the study is looking for

  • 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.

Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mount Sinai Chelsea
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai West
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai-- Downtown Union Square
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.